Details for New Drug Application (NDA): 215891
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NDA 215891 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Chartwell Rx, Ingenus Pharms Llc, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in eighteen NDAs. It is available from forty-four 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 215891
| Tradename: | DICLOFENAC POTASSIUM |
| Applicant: | Torrent |
| Ingredient: | diclofenac potassium |
| Patents: | 0 |
Pharmacology for NDA: 215891
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 215891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 215891 | ANDA | Torrent Pharmaceuticals Limited | 13668-672 | 13668-672-64 | 9 PACKET in 1 CARTON (13668-672-64) / 1 POWDER, FOR SOLUTION in 1 PACKET (13668-672-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 22, 2025 | TE: | AB | RLD: | No | ||||
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