Details for New Drug Application (NDA): 075189
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NDA 075189 describes NABUMETONE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Chartwell Molecules, Chartwell Rx, Copley Pharm, Epic Pharma Llc, Impax Labs Inc, Invagen Pharms, Lgm Pharma, Nostrum Labs Inc, Oxford Pharms, Sciegen Pharms Inc, and Watson Labs, and is included in thirteen NDAs. It is available from twenty-five suppliers. Additional details are available on the NABUMETONE profile page.
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.
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 075189
| Tradename: | NABUMETONE |
| Applicant: | Impax Labs Inc |
| Ingredient: | nabumetone |
| Patents: | 0 |
Pharmacology for NDA: 075189
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 075189
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NABUMETONE | nabumetone | TABLET;ORAL | 075189 | ANDA | medsource pharmaceuticals | 45865-997 | 45865-997-60 | 60 TABLET, FILM COATED in 1 BOTTLE (45865-997-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | May 26, 2000 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | Sep 24, 2001 | TE: | RLD: | No | |||||
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