Details for New Drug Application (NDA): 076561
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The generic ingredient in CATAFLAM 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 076561
Tradename: | CATAFLAM |
Applicant: | Amici |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 076561
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 076561
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CATAFLAM | diclofenac potassium | TABLET;ORAL | 076561 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-180 | 15370-180-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10) |
CATAFLAM | diclofenac potassium | TABLET;ORAL | 076561 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-180 | 15370-180-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 18, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 21, 2021 | TE: | AB | RLD: | No |
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