Details for New Drug Application (NDA): 210078
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The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 210078
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Strides Pharma |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210078
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 210078
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 210078 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-840 | 23155-840-12 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-840-12) |
DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 210078 | ANDA | Chartwell RX, LLC | 62135-469 | 62135-469-12 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-469-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 3, 2019 | TE: | AB | RLD: | No |
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