Details for New Drug Application (NDA): 215576
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The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 215576
Tradename: | SUCRALFATE |
Applicant: | Amneal Pharms |
Ingredient: | sucralfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215576
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUCRALFATE | sucralfate | TABLET;ORAL | 215576 | ANDA | AvKARE | 42291-936 | 42291-936-90 | 90 TABLET in 1 BOTTLE (42291-936-90) |
SUCRALFATE | sucralfate | TABLET;ORAL | 215576 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1656 | 60219-1656-1 | 100 TABLET in 1 BOTTLE (60219-1656-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Apr 15, 2022 | TE: | AB | RLD: | No |
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