Details for New Drug Application (NDA): 075078
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The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 075078
Tradename: | ETODOLAC |
Applicant: | Taro |
Ingredient: | etodolac |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075078
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075078
Suppliers and Packaging for NDA: 075078
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | CAPSULE;ORAL | 075078 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4016 | 51672-4016-1 | 100 CAPSULE in 1 BOTTLE (51672-4016-1) |
ETODOLAC | etodolac | CAPSULE;ORAL | 075078 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4017 | 51672-4017-1 | 100 CAPSULE in 1 BOTTLE (51672-4017-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 30, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Apr 30, 1998 | TE: | AB | RLD: | No |
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