Details for New Drug Application (NDA): 215787
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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 215787
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Senores Pharms |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 215787
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 215787
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215787 | ANDA | Cintex Services, LLC | 24470-924 | 24470-924-60 | 60 TABLET in 1 BOTTLE (24470-924-60) |
DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 215787 | ANDA | Amici Pharmaceuticals LLC | 69292-552 | 69292-552-01 | 100 TABLET in 1 BOTTLE (69292-552-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 15, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 9, 2023 | TE: | AB | RLD: | No |
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