Details for New Drug Application (NDA): 085828
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The generic ingredient in SULFASALAZINE 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 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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