Details for New Drug Application (NDA): 216474
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NDA 216474 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-seven 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-three 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-three suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 216474
| Tradename: | SUCRALFATE |
| Applicant: | Strides Pharma |
| Ingredient: | sucralfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216474
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 216474 | ANDA | Strides Pharma Science Limited | 64380-149 | 64380-149-01 | 420 mL in 1 BOTTLE, PLASTIC (64380-149-01) |
| SUCRALFATE | sucralfate | SUSPENSION;ORAL | 216474 | ANDA | Strides Pharma Science Limited | 64380-149 | 64380-149-03 | 5 CUP, UNIT-DOSE in 1 TRAY (64380-149-03) / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | May 21, 2024 | TE: | AB | RLD: | No | ||||
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