Details for New Drug Application (NDA): 072050
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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 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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