Details for New Drug Application (NDA): 075463
✉ Email this page to a colleague
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 075463
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Rk Pharma |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 075463
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075463
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075463 | ANDA | NuCare Pharmaceuticals, Inc. | 68071-3718 | 68071-3718-3 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3718-3) |
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075463 | ANDA | Archis Pharma LLC | 72819-151 | 72819-151-10 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72819-151-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 26, 1999 | TE: | AB | RLD: | No |
Complete Access Available with Subscription