Details for New Drug Application (NDA): 076561
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NDA 076561 describes CATAFLAM, which is a drug marketed by Amici Pharma and Novartis and is included in two NDAs. It is available from three suppliers. Additional details are available on the CATAFLAM profile page.
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.
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 Pharma |
| 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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