Details for New Drug Application (NDA): 209356
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The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 209356
Tradename: | SUCRALFATE |
Applicant: | Amneal |
Ingredient: | sucralfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 209356
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUCRALFATE | sucralfate | SUSPENSION;ORAL | 209356 | ANDA | AvKARE | 42291-781 | 42291-781-42 | 420 mL in 1 BOTTLE (42291-781-42) |
SUCRALFATE | sucralfate | SUSPENSION;ORAL | 209356 | ANDA | AvPAK | 50268-745 | 50268-745-14 | 40 CUP in 1 BOX (50268-745-14) / 10 mL in 1 CUP (50268-745-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
Approval Date: | Dec 2, 2019 | TE: | AB | RLD: | No |
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