Details for New Drug Application (NDA): 215750
NDA 215750 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, Pharmazone, Rising, Rubicon Research, 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 215750
| Tradename: | DICLOFENAC POTASSIUM |
| Applicant: | Umedica |
| Ingredient: | diclofenac potassium |
| Patents: | 0 |
Pharmacology for NDA: 215750
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 215750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215750 | ANDA | A-S Medication Solutions | 50090-6768 | 50090-6768-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6768-0) |
| DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215750 | ANDA | A-S Medication Solutions | 50090-6768 | 50090-6768-1 | 21 TABLET, FILM COATED in 1 BOTTLE (50090-6768-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 11, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 30, 2025 | TE: | AB | RLD: | No | ||||
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