Details for New Drug Application (NDA): 075229
✉ 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 075229
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Rubicon |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 075229
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075229
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075229 | ANDA | A-S Medication Solutions | 50090-5893 | 50090-5893-0 | 30 TABLET, COATED in 1 BOTTLE (50090-5893-0) |
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075229 | ANDA | A-S Medication Solutions | 50090-5893 | 50090-5893-1 | 21 TABLET, COATED in 1 BOTTLE (50090-5893-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 20, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 16, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription