Details for New Drug Application (NDA): 091134
✉ Email this page to a colleague
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 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 |
Complete Access Available with Subscription