Details for New Drug Application (NDA): 075126
✉ 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 075126
Tradename: | ETODOLAC |
Applicant: | Ani Pharms |
Ingredient: | etodolac |
Patents: | 0 |
Pharmacology for NDA: 075126
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075126
Suppliers and Packaging for NDA: 075126
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | CAPSULE;ORAL | 075126 | ANDA | A-S Medication Solutions | 50090-2132 | 50090-2132-1 | 21 CAPSULE in 1 BOTTLE (50090-2132-1) |
ETODOLAC | etodolac | CAPSULE;ORAL | 075126 | ANDA | ANI Pharmaceuticals, Inc. | 62559-250 | 62559-250-01 | 100 CAPSULE in 1 BOTTLE (62559-250-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 16, 1999 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Sep 16, 1999 | TE: | AB | RLD: | No |
Complete Access Available with Subscription