Details for New Drug Application (NDA): 075829
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NDA 075829 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-one 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-one 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-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075829
| Tradename: | ETODOLAC |
| Applicant: | Watson Labs Florida |
| Ingredient: | etodolac |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075829
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 30, 2001 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 30, 2001 | TE: | RLD: | No | |||||
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