Details for New Drug Application (NDA): 091134
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NDA 091134 describes ETODOLAC, which is a drug marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Abraxeolus, Adaptis, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the ETODOLAC profile page.
The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the etodolac profile page.
The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 091134
| Tradename: | ETODOLAC |
| Applicant: | Zydus Pharms |
| Ingredient: | etodolac |
| Patents: | 0 |
Pharmacology for NDA: 091134
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091134
Suppliers and Packaging for NDA: 091134
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 091134 | ANDA | St. Mary's Medical Park Pharmacy | 60760-298 | 60760-298-15 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-298-15) |
| ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 091134 | ANDA | Proficient Rx LP | 63187-374 | 63187-374-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Jan 23, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jan 23, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 23, 2014 | TE: | AB | RLD: | No | ||||
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