Details for New Drug Application (NDA): 091083
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The generic ingredient in NABUMETONE is nabumetone. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 091083
Tradename: | NABUMETONE |
Applicant: | Watson Labs |
Ingredient: | nabumetone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091083
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 091083
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NABUMETONE | nabumetone | TABLET;ORAL | 091083 | ANDA | Actavis Pharma, Inc. | 0591-3670 | 0591-3670-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-01) |
NABUMETONE | nabumetone | TABLET;ORAL | 091083 | ANDA | Actavis Pharma, Inc. | 0591-3670 | 0591-3670-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 13, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Jun 13, 2011 | TE: | AB | RLD: | No |
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