Details for New Drug Application (NDA): 203166
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NDA 203166 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 203166
| Tradename: | NABUMETONE |
| Applicant: | Lgm Pharma |
| Ingredient: | nabumetone |
| Patents: | 0 |
Pharmacology for NDA: 203166
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 203166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NABUMETONE | nabumetone | TABLET;ORAL | 203166 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-170 | 15370-170-10 | 100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10) |
| NABUMETONE | nabumetone | TABLET;ORAL | 203166 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-170 | 15370-170-30 | 30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | Aug 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Aug 30, 2019 | TE: | RLD: | No | |||||
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