Details for New Drug Application (NDA): 075665
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NDA 075665 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, Amneal Pharms Co, Apotex Inc, Edenbridge Pharms, Ivax Sub Teva Pharms, Oxford Pharms, Pangea, 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.
Pharmacology for NDA: 075665
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075665
Suppliers and Packaging for NDA: 075665
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 075665 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1118 | 0093-1118-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1118-01) |
| ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 075665 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1122 | 0093-1122-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1122-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Jul 31, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 31, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Feb 5, 2001 | TE: | AB | RLD: | No | ||||
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