Paracetamol Rx - FDA Approved Drugs
Paracetamol Rx
FDA approved drug product records including application numbers, product numbers, active ingredients, dosage forms, strengths, approval dates and regulatory status.
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FDA Approved Drug Records (202 records)
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/50ML (10MG/ML)
Approval Date
Feb 18, 2021
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 204957
Product No.: 1
Product
Dosage Form: -
Strength: 500MG/50ML (10MG/ML)
Approval Date
Feb 18, 2021
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Feb 18, 2021
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 204957
Product No.: 2
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Feb 18, 2021
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
May 03, 2023
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 215403
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
May 03, 2023
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Jul 27, 2022
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 216617
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Jul 27, 2022
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Dec 05, 2025
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 219096
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Dec 05, 2025
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
May 29, 2008
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 40779
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
May 29, 2008
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
Sep 30, 1988
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 89805
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
Sep 30, 1988
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
Sep 30, 1988
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 89828
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
Sep 30, 1988
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
Sep 30, 1988
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 89990
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;15MG
Approval Date
Sep 30, 1988
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
Jun 27, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 211610
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;15MG
Approval Date
Jun 27, 2019
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
Jun 27, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 211610
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
Jun 27, 2019
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
3
Dosage Form
-
Strength
300MG;60MG
Approval Date
Jun 27, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 211610
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
Jun 27, 2019
Regulatory Status
RX
Drug Name
ALLZITAL
Product Number
1
Dosage Form
-
Strength
325MG;25MG
Approval Date
Dec 04, 2015
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 203484
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;25MG
Approval Date
Dec 04, 2015
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;50MG
Approval Date
Dec 04, 2015
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 203484
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;50MG
Approval Date
Dec 04, 2015
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Dec 27, 2017
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 207313
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Dec 27, 2017
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Nov 22, 2019
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 213115
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Nov 22, 2019
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Apr 07, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214088
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Apr 07, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;25MG
Approval Date
Apr 07, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214088
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;25MG
Approval Date
Apr 07, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;50MG
Approval Date
Apr 07, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214088
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;50MG
Approval Date
Apr 07, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;50MG
Approval Date
Jan 18, 2024
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214291
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG
Approval Date
Jan 18, 2024
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Feb 01, 2024
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214305
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Feb 01, 2024
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Aug 16, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 214955
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Aug 16, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG/15ML;50MG/15ML;40MG/15ML
Approval Date
Jan 31, 2003
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 40387
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/15ML;50MG/15ML;40MG/15ML
Approval Date
Jan 31, 2003
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Dec 01, 2008
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 40864
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Dec 01, 2008
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Mar 17, 1986
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 89007
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Mar 17, 1986
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Sep 13, 2012
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 200243
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Sep 13, 2012
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Oct 28, 2016
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 207118
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Oct 28, 2016
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Dec 17, 2019
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 210817
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Dec 17, 2019
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Sep 26, 2018
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 211106
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Sep 26, 2018
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Dec 17, 2019
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 212082
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Dec 17, 2019
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Dec 17, 2019
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 212083
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Dec 17, 2019
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Apr 08, 2020
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 213321
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Apr 08, 2020
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Aug 13, 2021
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 214087
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Aug 13, 2021
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
2
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Aug 13, 2021
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 214087
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Aug 13, 2021
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Jan 18, 2024
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 214287
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Jan 18, 2024
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Feb 08, 2024
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 214288
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Feb 08, 2024
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Nov 17, 2021
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 215047
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Nov 17, 2021
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Mar 12, 2024
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 216376
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Mar 12, 2024
Regulatory Status
RX
Drug Name
COMBOGESIC
Product Number
1
Dosage Form
-
Strength
325MG;97.5MG
Approval Date
Mar 01, 2023
Active Ingredient
ACETAMINOPHEN; IBUPROFEN
Identifiers
Application No.: 209471
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;97.5MG
Approval Date
Mar 01, 2023
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Aug 25, 2006
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40736
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Aug 25, 2006
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;10MG
Approval Date
Aug 25, 2006
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40746
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Aug 25, 2006
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
May 10, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40746
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
May 10, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;7.5MG/15ML
Approval Date
Jul 19, 2011
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40894
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML
Approval Date
Jul 19, 2011
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jun 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202935
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jun 15, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jun 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202935
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jun 15, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jun 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202935
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jun 15, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
Jun 20, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207171
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Jun 20, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Jun 20, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207171
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Jun 20, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
Jun 20, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207171
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Jun 20, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jun 22, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207172
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jun 22, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jun 22, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207172
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jun 22, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jun 22, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207172
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jun 22, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
Oct 29, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207509
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Oct 29, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Oct 29, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207509
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Oct 29, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
Oct 29, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207509
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Oct 29, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209036
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209036
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209036
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209037
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209037
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jun 21, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209037
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jun 21, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Nov 07, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211487
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Nov 07, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Nov 07, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211487
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Nov 07, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Nov 07, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211487
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Nov 07, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Nov 07, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211487
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Nov 07, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jan 03, 2020
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211729
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jan 03, 2020
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jan 03, 2020
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211729
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jan 03, 2020
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jan 03, 2020
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211729
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jan 03, 2020
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Nov 27, 2007
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40777
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Nov 27, 2007
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;10MG
Approval Date
Nov 27, 2007
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40778
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Nov 27, 2007
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jun 27, 2014
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40778
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jun 27, 2014
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Sep 25, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207333
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Sep 25, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;10MG
Approval Date
Sep 25, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207333
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Sep 25, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Mar 22, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207419
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Mar 22, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Mar 22, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207419
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Mar 22, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Mar 22, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207419
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Mar 22, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Mar 22, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207419
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Mar 22, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Feb 09, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 210644
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Feb 09, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Feb 09, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 210644
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Feb 09, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Feb 09, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 210644
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Feb 09, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Feb 09, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 210644
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Feb 09, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/5ML;5MG/5ML
Approval Date
Dec 31, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 211499
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/5ML;5MG/5ML
Approval Date
Dec 31, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Oct 31, 2019
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 211708
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Oct 31, 2019
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Oct 31, 2019
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 211708
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Oct 31, 2019
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Oct 31, 2019
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 211708
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Oct 31, 2019
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Oct 31, 2019
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 211708
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Oct 31, 2019
Regulatory Status
RX
Drug Name
PERCOCET
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Jun 25, 1999
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40330
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Jun 25, 1999
Regulatory Status
RX
Drug Name
PERCOCET
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jun 25, 1999
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40330
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jun 25, 1999
Regulatory Status
RX
Drug Name
PERCOCET
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Nov 23, 2001
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40330
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Nov 23, 2001
Regulatory Status
RX
Drug Name
PERCOCET
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Nov 23, 2001
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40330
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Nov 23, 2001
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
Sep 26, 2008
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Identifiers
Application No.: 77858
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;37.5MG
Approval Date
Sep 26, 2008
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
Sep 06, 2012
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Identifiers
Application No.: 90460
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;37.5MG
Approval Date
Sep 06, 2012
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Apr 18, 2023
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 205746
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Apr 18, 2023
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
Apr 15, 2013
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 202800
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;15MG
Approval Date
Apr 15, 2013
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
Apr 15, 2013
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 202800
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
Apr 15, 2013
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
3
Dosage Form
-
Strength
300MG;60MG
Approval Date
Apr 15, 2013
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 202800
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
Apr 15, 2013
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Sep 26, 2018
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 204733
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Sep 26, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Apr 11, 2012
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 201013
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Apr 11, 2012
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Apr 11, 2012
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 201013
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Apr 11, 2012
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Apr 11, 2012
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 201013
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Apr 11, 2012
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
Sep 13, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207709
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Sep 13, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Sep 13, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207709
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Sep 13, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
Sep 13, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 207709
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Sep 13, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Jul 15, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201972
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Jul 15, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jul 15, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201972
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jul 15, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jul 15, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201972
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jul 15, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jul 15, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201972
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jul 15, 2013
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
Sep 10, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 212418
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;15MG
Approval Date
Sep 10, 2019
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
Sep 10, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 212418
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
Sep 10, 2019
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
3
Dosage Form
-
Strength
300MG;60MG
Approval Date
Sep 10, 2019
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 212418
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
Sep 10, 2019
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Nov 16, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209924
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Nov 16, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Nov 16, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209924
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Nov 16, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Nov 16, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209924
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Nov 16, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Nov 16, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 209924
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Nov 16, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 209385
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 209385
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 209385
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Feb 24, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 204407
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Feb 24, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Feb 24, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 204407
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Feb 24, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Feb 24, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 204407
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Feb 24, 2017
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Feb 24, 2017
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 204407
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Feb 24, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Oct 30, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 210211
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Oct 30, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Oct 30, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 210211
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Oct 30, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Oct 30, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 210211
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Oct 30, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;7.5MG/15ML
Approval Date
Mar 08, 2019
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 211023
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML
Approval Date
Mar 08, 2019
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Mar 21, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207510
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Mar 21, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Mar 21, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207510
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Mar 21, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Mar 21, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 207510
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Mar 21, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;10MG/15ML
Approval Date
Apr 18, 2008
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40834
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/15ML;10MG/15ML
Approval Date
Apr 18, 2008
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;7.5MG/15ML
Approval Date
May 10, 2013
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40838
Product No.: 1
Product
Dosage Form: -
Strength: 325MG/15ML;7.5MG/15ML
Approval Date
May 10, 2013
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Apr 12, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202991
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Apr 12, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Apr 12, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202991
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Apr 12, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Apr 12, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202991
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Apr 12, 2016
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Aug 28, 2014
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201278
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Aug 28, 2014
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Aug 28, 2014
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201278
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Aug 28, 2014
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Aug 28, 2014
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201278
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Aug 28, 2014
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Nov 09, 1984
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 88616
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Nov 09, 1984
Regulatory Status
RX
Drug Name
FIORICET W/ CODEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG;30MG
Approval Date
Jul 30, 1992
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Identifiers
Application No.: 20232
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG;30MG
Approval Date
Jul 30, 1992
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
Apr 12, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201447
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;2.5MG
Approval Date
Apr 12, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;5MG
Approval Date
Apr 12, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201447
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Apr 12, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Apr 12, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201447
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Apr 12, 2013
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
325MG;10MG
Approval Date
Apr 12, 2013
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 201447
Product No.: 4
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Apr 12, 2013
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
Mar 30, 2012
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Identifiers
Application No.: 202076
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;37.5MG
Approval Date
Mar 30, 2012
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
Dec 09, 2009
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Identifiers
Application No.: 90485
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;37.5MG
Approval Date
Dec 09, 2009
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
Mar 22, 2017
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Identifiers
Application No.: 207152
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;37.5MG
Approval Date
Mar 22, 2017
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Sep 17, 2021
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 214331
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Sep 17, 2021
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
650MG/65ML (10MG/ML)
Approval Date
May 21, 2025
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 214331
Product No.: 2
Product
Dosage Form: -
Strength: 650MG/65ML (10MG/ML)
Approval Date
May 21, 2025
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Mar 30, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 203863
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Mar 30, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Mar 30, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 203863
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Mar 30, 2018
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Mar 30, 2018
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 203863
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Mar 30, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 203864
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 203864
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jul 02, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 203864
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jul 02, 2018
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/50ML (10MG/ML)
Approval Date
Apr 02, 2025
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 219215
Product No.: 1
Product
Dosage Form: -
Strength: 500MG/50ML (10MG/ML)
Approval Date
Apr 02, 2025
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Apr 02, 2025
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 219215
Product No.: 2
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Apr 02, 2025
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Jun 13, 2016
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 202605
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Jun 13, 2016
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Jun 03, 2022
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 206968
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Jun 03, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG;30MG
Approval Date
Jan 26, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Identifiers
Application No.: 215138
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG;30MG
Approval Date
Jan 26, 2022
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;50MG;40MG;30MG
Approval Date
Jan 26, 2022
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Identifiers
Application No.: 215138
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;50MG;40MG;30MG
Approval Date
Jan 26, 2022
Regulatory Status
RX
Drug Name
COMBOGESIC IV
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Approval Date
Oct 17, 2023
Active Ingredient
ACETAMINOPHEN; IBUPROFEN SODIUM
Identifiers
Application No.: 215320
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Approval Date
Oct 17, 2023
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;15MG
Approval Date
May 31, 2001
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 40419
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;15MG
Approval Date
May 31, 2001
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;30MG
Approval Date
May 31, 2001
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 40419
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;30MG
Approval Date
May 31, 2001
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
3
Dosage Form
-
Strength
300MG;60MG
Approval Date
May 31, 2001
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 40419
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
May 31, 2001
Regulatory Status
RX
Drug Name
ANEXSIA 5/325
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Oct 20, 2000
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40409
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Oct 20, 2000
Regulatory Status
RX
Drug Name
ANEXSIA 7.5/325
Product Number
1
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Sep 08, 2000
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40405
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Sep 08, 2000
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jul 26, 2000
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40400
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jul 26, 2000
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
Mar 31, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 206718
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Mar 31, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Mar 31, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 206718
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Mar 31, 2017
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
Mar 31, 2017
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 206718
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Mar 31, 2017
Regulatory Status
RX
Drug Name
OXYCET
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Dec 07, 1983
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 87463
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Dec 07, 1983
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jun 30, 2004
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40545
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jun 30, 2004
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jun 30, 2004
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40545
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jun 30, 2004
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Jan 21, 1987
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 89175
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Jan 21, 1987
Regulatory Status
RX
Drug Name
BUTAPAP
Product Number
1
Dosage Form
-
Strength
325MG;50MG
Approval Date
Oct 26, 1992
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 89987
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG
Approval Date
Oct 26, 1992
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG/15ML;10MG/15ML
Approval Date
Feb 25, 2010
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 40881
Product No.: 1
Product
Dosage Form: -
Strength: 300MG/15ML;10MG/15ML
Approval Date
Feb 25, 2010
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;2.5MG
Approval Date
Dec 30, 2005
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40608
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;2.5MG
Approval Date
Dec 30, 2005
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;5MG
Approval Date
Dec 30, 2005
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40608
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Dec 30, 2005
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Dec 30, 2005
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40608
Product No.: 3
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Dec 30, 2005
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
300MG;10MG
Approval Date
Dec 30, 2005
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 40608
Product No.: 4
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Dec 30, 2005
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG/5ML;10MG/5ML
Approval Date
Nov 27, 2018
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 202142
Product No.: 1
Product
Dosage Form: -
Strength: 300MG/5ML;10MG/5ML
Approval Date
Nov 27, 2018
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Aug 07, 2020
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 213255
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Aug 07, 2020
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Mar 22, 2016
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 204052
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Mar 22, 2016
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
Jan 01, 1982
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 87083
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;60MG
Approval Date
Jan 01, 1982
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Jul 01, 2020
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 213046
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Jul 01, 2020
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
Mar 27, 2013
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Mar 27, 2013
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Mar 27, 2013
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Mar 27, 2013
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
Mar 27, 2013
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Mar 27, 2013
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
300MG;5MG
Approval Date
Mar 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 4
Product
Dosage Form: -
Strength: 300MG;5MG
Approval Date
Mar 15, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
5
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
Mar 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 5
Product
Dosage Form: -
Strength: 300MG;7.5MG
Approval Date
Mar 15, 2016
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
6
Dosage Form
-
Strength
300MG;10MG
Approval Date
Mar 15, 2016
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Identifiers
Application No.: 202214
Product No.: 6
Product
Dosage Form: -
Strength: 300MG;10MG
Approval Date
Mar 15, 2016
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Aug 23, 2011
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 90956
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Aug 23, 2011
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
300MG;50MG;40MG
Approval Date
Nov 16, 2009
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 40885
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG;40MG
Approval Date
Nov 16, 2009
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
Oct 31, 2018
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Identifiers
Application No.: 209587
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG
Approval Date
Oct 31, 2018
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG;30MG
Approval Date
Jun 10, 2004
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Identifiers
Application No.: 76560
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;50MG;40MG;30MG
Approval Date
Jun 10, 2004
Regulatory Status
RX
Drug Name
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;50MG;40MG;30MG
Approval Date
Jul 19, 2012
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Identifiers
Application No.: 76560
Product No.: 2
Product
Dosage Form: -
Strength: 300MG;50MG;40MG;30MG
Approval Date
Jul 19, 2012
Regulatory Status
RX
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
120MG/5ML;12MG/5ML
Approval Date
Jan 01, 1982
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Identifiers
Application No.: 87508
Product No.: 1
Product
Dosage Form: -
Strength: 120MG/5ML;12MG/5ML
Approval Date
Jan 01, 1982
Regulatory Status
RX
Drug Name
BUTALBITAL AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;50MG
Approval Date
Nov 15, 2016
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Identifiers
Application No.: 207386
Product No.: 1
Product
Dosage Form: -
Strength: 300MG;50MG
Approval Date
Nov 15, 2016
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Oct 21, 2020
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 210969
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Oct 21, 2020
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
Oct 28, 2015
Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 204767
Product No.: 1
Product
Dosage Form: -
Strength: 1GM/100ML (10MG/ML)
Approval Date
Oct 28, 2015
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
Jul 26, 2012
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 202677
Product No.: 1
Product
Dosage Form: -
Strength: 325MG;7.5MG
Approval Date
Jul 26, 2012
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;10MG
Approval Date
Jul 26, 2012
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 202677
Product No.: 2
Product
Dosage Form: -
Strength: 325MG;10MG
Approval Date
Jul 26, 2012
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;5MG
Approval Date
Mar 08, 2016
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Identifiers
Application No.: 202677
Product No.: 3
Product
Dosage Form: -
Strength: 325MG;5MG
Approval Date
Mar 08, 2016
Regulatory Status
RX
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Related Databases
5 of 6 have recordsDrug Status Breakdown
202 total- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Active Ingredient
ACETAMINOPHEN
Identifiers
Application No.: 204957
Product No.: 1
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