Details for New Drug Application (NDA): 075492
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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. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 075492
Tradename: | DICLOFENAC SODIUM |
Applicant: | Vpna |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 075492
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075492
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | TABLET, EXTENDED RELEASE;ORAL | 075492 | ANDA | A-S Medication Solutions | 50090-4172 | 50090-4172-1 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4172-1) |
DICLOFENAC SODIUM | diclofenac sodium | TABLET, EXTENDED RELEASE;ORAL | 075492 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1792 | 53002-1792-1 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-1792-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 11, 2000 | TE: | AB | RLD: | No |
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