Details for New Drug Application (NDA): 211253
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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 211253
Tradename: | DICLOFENAC SODIUM |
Applicant: | Perrigo Pharma Intl |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 211253
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 211253
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 211253 | ANDA | L. Perrigo Company | 0113-1189 | 0113-1189-01 | 1 TUBE in 1 CARTON (0113-1189-01) / 100 g in 1 TUBE |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 211253 | ANDA | L. Perrigo Company | 0113-1189 | 0113-1189-03 | 150 g in 1 TUBE (0113-1189-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | May 16, 2019 | TE: | RLD: | No |
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