Details for New Drug Application (NDA): 211884
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NDA 211884 describes SUCRALFATE, which is a drug marketed by Abon Pharms Llc, Amneal, Hikma, Mylan, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Nostrum Labs Inc, Teva, and Zydus Lifesciences, and is included in eleven NDAs. It is available from thirty-five suppliers. Additional details are available on the SUCRALFATE profile page.
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.
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 211884
| Tradename: | SUCRALFATE |
| Applicant: | Vistapharm Llc |
| Ingredient: | sucralfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211884
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 211884 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0974 | 0121-0974-00 | 10 TRAY in 1 TRAY (0121-0974-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) |
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 211884 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0974 | 0121-0974-40 | 4 TRAY in 1 CASE (0121-0974-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Mar 15, 2022 | TE: | AB | RLD: | No | ||||
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