Details for New Drug Application (NDA): 206298
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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 206298
Tradename: | DICLOFENAC SODIUM |
Applicant: | Taro |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206298
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 206298
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 206298 | ANDA | Medsource Pharmaceuticals | 45865-237 | 45865-237-01 | 100 g in 1 TUBE (45865-237-01) |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 206298 | ANDA | UNIT DOSE SERVICES. | 50436-0356 | 50436-0356-1 | 1 TUBE in 1 CARTON (50436-0356-1) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 3% | ||||
Approval Date: | Apr 28, 2016 | TE: | AB | RLD: | No |
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