Details for New Drug Application (NDA): 211780
The generic ingredient in SUCRALFATE is sucralfate. There is one drug master file entry for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 211780
| Tradename: | SUCRALFATE |
| Applicant: | Chartwell Rx |
| Ingredient: | sucralfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211780
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 211780 | ANDA | Chartwell RX, LLC | 62135-106 | 62135-106-44 | 420 mL in 1 BOTTLE (62135-106-44) |
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 211780 | ANDA | Chartwell Governmental & Specialty RX, LLC | 68999-106 | 68999-106-24 | 2 TRAY in 1 BOX (68999-106-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-106-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Apr 14, 2025 | TE: | AB | RLD: | No | ||||
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