Details for New Drug Application (NDA): 204132
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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 204132
Tradename: | DICLOFENAC SODIUM |
Applicant: | Lupin Ltd |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204132
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 204132
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 204132 | ANDA | medsource pharmaceuticals | 45865-878 | 45865-878-01 | 150 mL in 1 BOTTLE (45865-878-01) |
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 204132 | ANDA | Quality Care Products, LLC | 55700-931 | 55700-931-15 | 1 BOTTLE in 1 CARTON (55700-931-15) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1.5% | ||||
Approval Date: | Aug 20, 2015 | TE: | AT | RLD: | No |
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