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 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 |
Formulation / Manufacturing: | see details |
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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