Details for New Drug Application (NDA): 075219
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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 075219
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Teva |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 075219
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075219
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075219 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0948 | 0093-0948-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0948-01) |
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075219 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0948 | 0093-0948-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0948-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 6, 1998 | TE: | AB | RLD: | No |
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