Details for New Drug Application (NDA): 212351
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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 212351
Tradename: | DICLOFENAC SODIUM |
Applicant: | Alembic |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 212351
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 212351
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 212351 | ANDA | Medsource Pharmaceuticals | 45865-260 | 45865-260-01 | 100 g in 1 TUBE (45865-260-01) |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 212351 | ANDA | Alembic Pharmaceuticals Inc. | 62332-581 | 62332-581-31 | 1 TUBE in 1 CARTON (62332-581-31) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 3% | ||||
Approval Date: | Jul 27, 2022 | TE: | AB | RLD: | No |
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