Details for New Drug Application (NDA): 213875
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NDA 213875 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Chartwell Rx, Ingenus Pharms Llc, Rising, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in eighteen NDAs. It is available from forty-five suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.
The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There is one drug master file entry for this compound. Fifty 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 is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 213875
| Tradename: | DICLOFENAC POTASSIUM |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | diclofenac potassium |
| Patents: | 0 |
Pharmacology for NDA: 213875
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 213875
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 213875 | ANDA | Aurobindo Pharma Limited | 59651-353 | 59651-353-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-01) |
| DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 213875 | ANDA | Aurobindo Pharma Limited | 59651-353 | 59651-353-08 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 19, 2021 | TE: | AB | RLD: | No | ||||
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