Details for New Drug Application (NDA): 072711
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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 072711
Tradename: | SULINDAC |
Applicant: | Epic Pharma |
Ingredient: | sulindac |
Patents: | 0 |
Pharmacology for NDA: 072711
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 072711
Suppliers and Packaging for NDA: 072711
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULINDAC | sulindac | TABLET;ORAL | 072711 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-771 | 24658-771-01 | 100 TABLET in 1 BOTTLE (24658-771-01) |
SULINDAC | sulindac | TABLET;ORAL | 072711 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-771 | 24658-771-05 | 500 TABLET in 1 BOTTLE (24658-771-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 25, 1991 | TE: | AB | RLD: | No |
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