Details for New Drug Application (NDA): 074514
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The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 074514
Tradename: | DICLOFENAC SODIUM |
Applicant: | Actavis Elizabeth |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074514
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 074514
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074514 | ANDA | Actavis Pharma, Inc. | 0228-2550 | 0228-2550-06 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06) |
DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074514 | ANDA | Actavis Pharma, Inc. | 0228-2550 | 0228-2550-11 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 26, 1996 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 75MG | ||||
Approval Date: | Mar 26, 1996 | TE: | AB | RLD: | No |
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