Details for New Drug Application (NDA): 208834
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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 208834
Tradename: | ETODOLAC |
Applicant: | Amneal Pharms Co |
Ingredient: | etodolac |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208834
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208834
Suppliers and Packaging for NDA: 208834
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | TABLET;ORAL | 208834 | ANDA | A-S Medication Solutions | 50090-3963 | 50090-3963-0 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-3963-0) |
ETODOLAC | etodolac | TABLET;ORAL | 208834 | ANDA | A-S Medication Solutions | 50090-3963 | 50090-3963-1 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3963-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Jun 7, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 7, 2018 | TE: | AB | RLD: | No |
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