Details for New Drug Application (NDA): 071795
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NDA 071795 describes SULINDAC, which is a drug marketed by Ani Pharms, Chartwell Rx, Epic Pharma, Epic Pharma Llc, Rising, Sun Pharm Industries, and Watson Labs, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the SULINDAC profile page.
The generic ingredient in SULINDAC is sulindac. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulindac profile page.
The generic ingredient in SULINDAC is sulindac. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulindac profile page.
Summary for 071795
| Tradename: | SULINDAC |
| Applicant: | Watson Labs |
| Ingredient: | sulindac |
| Patents: | 0 |
Pharmacology for NDA: 071795
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 071795
Suppliers and Packaging for NDA: 071795
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULINDAC | sulindac | TABLET;ORAL | 071795 | ANDA | Actavis Pharma, Inc. | 0591-5660 | 0591-5660-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5660-01) |
| SULINDAC | sulindac | TABLET;ORAL | 071795 | ANDA | Actavis Pharma, Inc. | 0591-5660 | 0591-5660-05 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-5660-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 3, 1990 | TE: | AB | RLD: | No | ||||
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