Details for New Drug Application (NDA): 072050
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NDA 072050 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 eight 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the sulindac profile page.
Summary for 072050
| Tradename: | SULINDAC |
| Applicant: | Sun Pharm Industries |
| Ingredient: | sulindac |
| Patents: | 0 |
Pharmacology for NDA: 072050
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 072050
Suppliers and Packaging for NDA: 072050
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULINDAC | sulindac | TABLET;ORAL | 072050 | ANDA | Major Pharmaceuticals | 0904-7334 | 0904-7334-60 | 100 TABLET in 1 BOTTLE, PLASTIC (0904-7334-60) |
| SULINDAC | sulindac | TABLET;ORAL | 072050 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-478 | 53489-478-01 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-478-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 17, 1991 | TE: | AB | RLD: | No | ||||
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