Details for New Drug Application (NDA): 213549
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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 213549
Tradename: | SUCRALFATE |
Applicant: | Pd Partners |
Ingredient: | sucralfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213549
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUCRALFATE | sucralfate | SUSPENSION;ORAL | 213549 | ANDA | TruPharma, LLC | 52817-840 | 52817-840-16 | 473 mL in 1 BOTTLE (52817-840-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
Approval Date: | Jan 17, 2024 | TE: | AB | RLD: | No |
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