Details for New Drug Application (NDA): 212913
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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 212913
Tradename: | SUCRALFATE |
Applicant: | Mylan |
Ingredient: | sucralfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 212913
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUCRALFATE | sucralfate | SUSPENSION;ORAL | 212913 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9205 | 0378-9205-35 | 420 mL in 1 BOTTLE, PLASTIC (0378-9205-35) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
Approval Date: | Sep 12, 2022 | TE: | AB | RLD: | No |
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