Details for New Drug Application (NDA): 074903
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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 074903
Tradename: | ETODOLAC |
Applicant: | Abraxeolus |
Ingredient: | etodolac |
Patents: | 0 |
Pharmacology for NDA: 074903
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074903
Suppliers and Packaging for NDA: 074903
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | TABLET;ORAL | 074903 | ANDA | Eon Labs, Inc. | 0185-0675 | 0185-0675-01 | 100 TABLET, COATED in 1 BOTTLE (0185-0675-01) |
ETODOLAC | etodolac | TABLET;ORAL | 074903 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-834 | 43063-834-60 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-834-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Apr 11, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 19, 1999 | TE: | AB | RLD: | No |
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