Mikart
FDA Approved Drugs
Mikart
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 48
- Latest Approval Date Jun 12, 2023
- Data Source FDA
- First Approval Date Feb 21, 1986
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Mikart
1750 Chattahoochee Ave. Atlanta, GA 30318
U.S.A
www.mikart.com/ bizdev@mikart.com View on MapFDA Approved Drug Records ( 48 records )
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
650MG;30MG
Approval Date
1986-03-03
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89231
Product Number
1
Dosage Form
-
Strength
650MG;30MG
Approval Date
1986-03-03
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
1986-02-25
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89238
Product Number
1
Dosage Form
-
Strength
300MG;30MG
Approval Date
1986-02-25
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1986-02-25
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89244
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1986-02-25
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
650MG;60MG
Approval Date
1991-09-09
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89363
Product Number
1
Dosage Form
-
Strength
650MG;60MG
Approval Date
1991-09-09
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
150MG;180MG;15MG
Approval Date
1990-10-26
Active Ingredient
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
Application Number
81095
Product Number
1
Dosage Form
-
Strength
150MG;180MG;15MG
Approval Date
1990-10-26
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
150MG;180MG;30MG
Approval Date
1990-10-26
Active Ingredient
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
Application Number
81096
Product Number
1
Dosage Form
-
Strength
150MG;180MG;30MG
Approval Date
1990-10-26
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
150MG;180MG;60MG
Approval Date
1990-10-26
Active Ingredient
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
Application Number
81097
Product Number
1
Dosage Form
-
Strength
150MG;180MG;60MG
Approval Date
1990-10-26
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
356.4MG;30MG;16MG
Approval Date
1997-08-26
Active Ingredient
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Application Number
40109
Product Number
1
Dosage Form
-
Strength
356.4MG;30MG;16MG
Approval Date
1997-08-26
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
712.8MG;60MG;32MG
Approval Date
1999-04-28
Active Ingredient
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Application Number
40316
Product Number
1
Dosage Form
-
Strength
712.8MG;60MG;32MG
Approval Date
1999-04-28
Regulatory Status
Discontinued
Drug Name
BENZONATATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2009-11-09
Active Ingredient
BENZONATATE
Application Number
40851
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2009-11-09
Regulatory Status
Discontinued
Drug Name
BENZONATATE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2009-11-09
Active Ingredient
BENZONATATE
Application Number
40851
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2009-11-09
Regulatory Status
Discontinued
Drug Name
BENZONATATE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2009-11-09
Active Ingredient
BENZONATATE
Application Number
40851
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2009-11-09
Regulatory Status
Discontinued
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
750MG;50MG;40MG
Approval Date
2003-12-23
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Application Number
40496
Product Number
1
Dosage Form
-
Strength
750MG;50MG;40MG
Approval Date
2003-12-23
Regulatory Status
Discontinued
Drug Name
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
1987-01-21
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Application Number
89175
Product Number
1
Dosage Form
-
Strength
325MG;50MG;40MG
Approval Date
1987-01-21
Regulatory Status
RX
Drug Name
BUTAPAP
Product Number
1
Dosage Form
-
Strength
325MG;50MG
Approval Date
1992-10-26
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Application Number
89987
Product Number
1
Dosage Form
-
Strength
325MG;50MG
Approval Date
1992-10-26
Regulatory Status
RX
Drug Name
BUTAPAP
Product Number
1
Dosage Form
-
Strength
650MG;50MG
Approval Date
1992-10-26
Active Ingredient
ACETAMINOPHEN; BUTALBITAL
Application Number
89988
Product Number
1
Dosage Form
-
Strength
650MG;50MG
Approval Date
1992-10-26
Regulatory Status
Discontinued
Drug Name
CARBINOXAMINE MALEATE
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2016-05-31
Active Ingredient
CARBINOXAMINE MALEATE
Application Number
207484
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2016-05-31
Regulatory Status
RX
Drug Name
ERGOTAMINE TARTRATE AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
100MG;1MG
Approval Date
2005-09-16
Active Ingredient
CAFFEINE; ERGOTAMINE TARTRATE
Application Number
40590
Product Number
1
Dosage Form
-
Strength
100MG;1MG
Approval Date
2005-09-16
Regulatory Status
RX
Drug Name
ESGIC-PLUS
Product Number
1
Dosage Form
-
Strength
500MG;50MG;40MG
Approval Date
1996-03-28
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Application Number
40085
Product Number
1
Dosage Form
-
Strength
500MG;50MG;40MG
Approval Date
1996-03-28
Regulatory Status
Discontinued
Drug Name
ESGIC-PLUS
Product Number
1
Dosage Form
-
Strength
500MG;50MG;40MG
Approval Date
1988-05-23
Active Ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Application Number
89451
Product Number
1
Dosage Form
-
Strength
500MG;50MG;40MG
Approval Date
1988-05-23
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
2010-06-09
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40846
Product Number
1
Dosage Form
-
Strength
325MG;2.5MG
Approval Date
2010-06-09
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;5MG
Approval Date
2010-06-09
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40849
Product Number
1
Dosage Form
-
Strength
650MG;5MG
Approval Date
2010-06-09
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG/15ML;10MG/15ML
Approval Date
2010-02-25
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40881
Product Number
1
Dosage Form
-
Strength
300MG/15ML;10MG/15ML
Approval Date
2010-02-25
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/15ML;7.5MG/15ML
Approval Date
1992-08-28
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81051
Product Number
1
Dosage Form
-
Strength
500MG/15ML;7.5MG/15ML
Approval Date
1992-08-28
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81067
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81068
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81069
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81070
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1989-11-30
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;10MG
Approval Date
1992-05-29
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81223
Product Number
1
Dosage Form
-
Strength
650MG;10MG
Approval Date
1992-05-29
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/15ML;5MG/15ML
Approval Date
1992-10-27
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
81226
Product Number
1
Dosage Form
-
Strength
500MG/15ML;5MG/15ML
Approval Date
1992-10-27
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1986-02-21
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89008
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1986-02-21
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1986-07-16
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89271
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1986-07-16
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG/15ML;5MG/15ML
Approval Date
1992-04-29
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89557
Product Number
1
Dosage Form
-
Strength
500MG/15ML;5MG/15ML
Approval Date
1992-04-29
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;7.5MG
Approval Date
1988-06-29
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89689
Product Number
1
Dosage Form
-
Strength
650MG;7.5MG
Approval Date
1988-06-29
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1992-01-28
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89697
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1992-01-28
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;2.5MG
Approval Date
1989-08-25
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89698
Product Number
1
Dosage Form
-
Strength
500MG;2.5MG
Approval Date
1989-08-25
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;7.5MG
Approval Date
1989-08-25
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
89699
Product Number
1
Dosage Form
-
Strength
500MG;7.5MG
Approval Date
1989-08-25
Regulatory Status
Discontinued
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2023-06-12
Active Ingredient
METHOCARBAMOL
Application Number
212707
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2023-06-12
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;2.5MG
Approval Date
2005-12-30
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40608
Product Number
1
Dosage Form
-
Strength
300MG;2.5MG
Approval Date
2005-12-30
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;5MG
Approval Date
2005-12-30
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40608
Product Number
2
Dosage Form
-
Strength
300MG;5MG
Approval Date
2005-12-30
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
2005-12-30
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40608
Product Number
3
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
2005-12-30
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
4
Dosage Form
-
Strength
300MG;10MG
Approval Date
2005-12-30
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40608
Product Number
4
Dosage Form
-
Strength
300MG;10MG
Approval Date
2005-12-30
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
2006-04-19
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40676
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
2006-04-19
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
400MG;2.5MG
Approval Date
2006-05-16
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40679
Product Number
1
Dosage Form
-
Strength
400MG;2.5MG
Approval Date
2006-05-16
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
400MG;5MG
Approval Date
2006-04-27
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40687
Product Number
1
Dosage Form
-
Strength
400MG;5MG
Approval Date
2006-04-27
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
400MG;10MG
Approval Date
2006-04-27
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40692
Product Number
1
Dosage Form
-
Strength
400MG;10MG
Approval Date
2006-04-27
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
400MG;7.5MG
Approval Date
2006-04-27
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
40698
Product Number
1
Dosage Form
-
Strength
400MG;7.5MG
Approval Date
2006-04-27
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG/5ML;10MG/5ML
Approval Date
2018-11-27
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
202142
Product Number
1
Dosage Form
-
Strength
300MG/5ML;10MG/5ML
Approval Date
2018-11-27
Regulatory Status
RX
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Drug Status Breakdown
48 total- Discontinued
- 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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Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Application Number
89231
Product Number
1
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form
-
Strength
650MG;30MG
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