Details for New Drug Application (NDA): 213875
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The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 213875
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 213875
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 213875
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 213875 | ANDA | Aurobindo Pharma Limited | 59651-353 | 59651-353-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-01) |
DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 213875 | ANDA | Aurobindo Pharma Limited | 59651-353 | 59651-353-08 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-353-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Oct 19, 2021 | TE: | AB | RLD: | No |
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