Details for New Drug Application (NDA): 218011
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The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 218011
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Taro |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 218011
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 218011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 218011 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4240 | 51672-4240-6 | 9 PACKET in 1 CARTON (51672-4240-6) / 1 POWDER, FOR SOLUTION in 1 PACKET (51672-4240-8) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No |
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