Details for New Drug Application (NDA): 085828
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NDA 085828 describes SULFASALAZINE, which is a drug marketed by Nuvo Pharms Inc, Watson Labs, Chartwell, Epic Pharma Llc, Sun Pharm Industries, and Superpharm, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the SULFASALAZINE profile page.
The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 085828
| Tradename: | SULFASALAZINE |
| Applicant: | Watson Labs |
| Ingredient: | sulfasalazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 085828
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFASALAZINE | sulfasalazine | TABLET;ORAL | 085828 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3234 | 0093-3234-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) |
| SULFASALAZINE | sulfasalazine | TABLET;ORAL | 085828 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3234 | 0093-3234-05 | 500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05) |
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: | No | ||||
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