Details for New Drug Application (NDA): 210704
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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 210704
Tradename: | ETODOLAC |
Applicant: | Bayshore Pharms Llc |
Ingredient: | etodolac |
Patents: | 0 |
Pharmacology for NDA: 210704
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 210704
Suppliers and Packaging for NDA: 210704
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | TABLET;ORAL | 210704 | ANDA | A-S Medication Solutions | 50090-6739 | 50090-6739-5 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6739-5) |
ETODOLAC | etodolac | TABLET;ORAL | 210704 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8580 | 68788-8580-6 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8580-6) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 16, 2020 | TE: | AB | RLD: | No |
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