Details for New Drug Application (NDA): 075074
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NDA 075074 describes ETODOLAC, which is a drug marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Actavis Elizabeth, Teva, Unichem, Watson Labs Florida, Zydus Pharms, Adaptis, Amneal Pharms Co, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Oxford Pharms, Pangea, Pharmaco, Ranbaxy Labs Ltd, Senores Pharms, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in forty NDAs. It is available from thirty suppliers. Additional details are available on the ETODOLAC profile page.
The generic ingredient in ETODOLAC is etodolac. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
The generic ingredient in ETODOLAC is etodolac. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075074
| Tradename: | ETODOLAC |
| Applicant: | Taro Pharm Inds |
| Ingredient: | etodolac |
| Patents: | 0 |
Pharmacology for NDA: 075074
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075074
Suppliers and Packaging for NDA: 075074
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | etodolac | TABLET;ORAL | 075074 | ANDA | A-S Medication Solutions | 50090-1489 | 50090-1489-5 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-1489-5) |
| ETODOLAC | etodolac | TABLET;ORAL | 075074 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4018 | 51672-4018-1 | 100 TABLET, FILM COATED in 1 BOTTLE (51672-4018-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Mar 11, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 25, 2000 | TE: | AB | RLD: | No | ||||
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