Details for New Drug Application (NDA): 007073
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The generic ingredient in AZULFIDINE is sulfasalazine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 007073
Tradename: | AZULFIDINE |
Applicant: | Pfizer |
Ingredient: | sulfasalazine |
Patents: | 0 |
Suppliers and Packaging for NDA: 007073
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZULFIDINE EN-TABS | sulfasalazine | TABLET, DELAYED RELEASE;ORAL | 007073 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-0101 | 0013-0101-10 | 1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE |
AZULFIDINE EN-TABS | sulfasalazine | TABLET, DELAYED RELEASE;ORAL | 007073 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-0101 | 0013-0101-30 | 1 BOTTLE in 1 CARTON (0013-0101-30) / 300 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 6, 1983 | TE: | AB | RLD: | Yes |
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