Details for New Drug Application (NDA): 215705
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The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 215705
| Tradename: | SUCRALFATE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | sucralfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215705
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCRALFATE | sucralfate | TABLET;ORAL | 215705 | ANDA | Coupler LLC | 67046-1469 | 67046-1469-3 | 30 TABLET in 1 BLISTER PACK (67046-1469-3) |
| SUCRALFATE | sucralfate | TABLET;ORAL | 215705 | ANDA | Redpharm Drug | 67296-2147 | 67296-2147-4 | 40 TABLET in 1 BOTTLE (67296-2147-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | May 3, 2023 | TE: | AB | RLD: | No | ||||
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