Details for New Drug Application (NDA): 076004
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The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 076004
Tradename: | ETODOLAC |
Applicant: | Apotex Inc |
Ingredient: | etodolac |
Patents: | 0 |
Pharmacology for NDA: 076004
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076004
Suppliers and Packaging for NDA: 076004
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | TABLET;ORAL | 076004 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-578 | 43063-578-20 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-578-20) |
ETODOLAC | etodolac | TABLET;ORAL | 076004 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-671 | 43063-671-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-671-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 3, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 3, 2002 | TE: | AB | RLD: | No |
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