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Details for New Drug Application (NDA): 070848
NDA 070848 describes SUCRALFATE, which is a drug marketed by Mylan Ireland Ltd and Teva and is included in two NDAs. It is available from eighteen 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. Twenty-six 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. Twenty-six suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 070848
| Tradename: | SUCRALFATE |
| Applicant: | Teva |
| Ingredient: | sucralfate |
| Patents: | 0 |
| Therapeutic Class: | Gastrointestinal Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070848
| Ingredient-type | Organometallic Compounds |
Medical Subject Heading (MeSH) Categories for 070848
Suppliers and Packaging for NDA: 070848
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCRALFATE | sucralfate | TABLET;ORAL | 070848 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-2210 | N | 0093-2210-01 |
| SUCRALFATE | sucralfate | TABLET;ORAL | 070848 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-2210 | N | 0093-2210-05 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Mar 29, 1996 | TE: | AB | RLD: | No | ||||
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