Details for New Drug Application (NDA): 080197
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NDA 080197 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 080197
| Tradename: | SULFASALAZINE |
| Applicant: | Chartwell |
| Ingredient: | sulfasalazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080197
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFASALAZINE | sulfasalazine | TABLET;ORAL | 080197 | ANDA | Chartwell RX, LLC. | 62135-960 | 62135-960-01 | 100 TABLET in 1 BOTTLE (62135-960-01) |
| SULFASALAZINE | sulfasalazine | TABLET;ORAL | 080197 | ANDA | Chartwell RX, LLC. | 62135-960 | 62135-960-05 | 500 TABLET in 1 BOTTLE (62135-960-05) |
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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