Details for New Drug Application (NDA): 080197
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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 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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