Details for New Drug Application (NDA): 204648
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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 204648
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Bionpharma |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 204648
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 204648
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 204648 | ANDA | TEVA PHARMACEUTICALS, INC. | 0480-9435 | 0480-9435-89 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-9435-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 23, 2016 | TE: | AB | RLD: | No |
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