Pharmaco
FDA Approved Drugs
Pharmaco
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 15
- Latest Approval Date Dec 16, 2020
- Data Source FDA
- First Approval Date Jan 01, 1982
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Pharmaco
Locked Bag 1009 Gordon NSW 2072
Australia
pharmaco.com.au/ enquiries@pharmaco.com.au View on MapFDA Approved Drug Records ( 15 records )
Drug Name
ETODOLAC
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2020-12-16
Active Ingredient
ETODOLAC
Application Number
210704
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2020-12-16
Regulatory Status
RX
Drug Name
ETODOLAC
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-16
Active Ingredient
ETODOLAC
Application Number
210704
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-16
Regulatory Status
RX
Drug Name
FENOPROFEN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
1988-08-17
Active Ingredient
FENOPROFEN CALCIUM
Application Number
72267
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
1988-08-17
Regulatory Status
Discontinued
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
91588
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2012-08-03
Regulatory Status
Discontinued
Drug Name
MONTELUKAST SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
91588
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-08-03
Regulatory Status
Discontinued
Drug Name
NALFON
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
FENOPROFEN CALCIUM
Application Number
17604
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NALFON
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
FENOPROFEN CALCIUM
Application Number
17604
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NALFON
Product Number
4
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-07-21
Active Ingredient
FENOPROFEN CALCIUM
Application Number
17604
Product Number
4
Dosage Form
-
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2009-07-21
Regulatory Status
Discontinued
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76882
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76882
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76882
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
77733
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
77733
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
77733
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
77733
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Regulatory Status
RX
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Drug Status Breakdown
15 total- RX
- Discontinued
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Explore important FDA approved drug information available in the records above.
Drug Name
ETODOLAC
Application Number
210704
Product Number
1
Active Ingredient
ETODOLAC
Dosage Form
-
Strength
400MG
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