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 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 |
Formulation / Manufacturing: | see details |
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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