Details for New Drug Application (NDA): 205878
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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 205878
Tradename: | DICLOFENAC SODIUM |
Applicant: | Novel Labs Inc |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205878
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 205878
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 205878 | ANDA | Novel Laboratories, Inc. | 40032-016 | 40032-016-61 | 1 BOTTLE in 1 CARTON (40032-016-61) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1.5% | ||||
Approval Date: | Dec 9, 2015 | TE: | AT | RLD: | No |
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