Details for New Drug Application (NDA): 206493
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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 206493
Tradename: | DICLOFENAC SODIUM |
Applicant: | Actavis Mid Atlantic |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 206493
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 206493
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 206493 | ANDA | Actavis Pharma, Inc. | 0472-1783 | 0472-1783-10 | 1 TUBE in 1 CARTON (0472-1783-10) / 100 g in 1 TUBE |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 206493 | ANDA | Proficient Rx LP | 71205-752 | 71205-752-00 | 1 TUBE in 1 CARTON (71205-752-00) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 3% | ||||
Approval Date: | Dec 2, 2015 | TE: | AB | RLD: | No |
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