Details for New Drug Application (NDA): 215585
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NDA 215585 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in sixteen NDAs. It is available from thirty-seven suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.
The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 215585
| Tradename: | DICLOFENAC POTASSIUM |
| Applicant: | Novast Labs |
| Ingredient: | diclofenac potassium |
| Patents: | 0 |
Pharmacology for NDA: 215585
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 215585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215585 | ANDA | AvKARE | 42291-042 | 42291-042-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-042-01) |
| DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215585 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-279 | 50742-279-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-279-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 8, 2021 | TE: | AB | RLD: | No | ||||
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