Details for New Drug Application (NDA): 007073
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NDA 007073 describes AZULFIDINE, which is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in two NDAs. It is available from five suppliers. Additional details are available on the AZULFIDINE profile page.
The generic ingredient in AZULFIDINE is sulfasalazine. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
The generic ingredient in AZULFIDINE is sulfasalazine. There are ten drug master file entries for this compound. Ten 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 |
| Formulation / Manufacturing: | see details |
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 | 0013-0101-01 | 100 TABLET in 1 BOTTLE (0013-0101-01) |
| 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 |
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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