Details for New Drug Application (NDA): 216635
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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 216635
Tradename: | DICLOFENAC POTASSIUM |
Applicant: | Alkem Labs Ltd |
Ingredient: | diclofenac potassium |
Patents: | 0 |
Pharmacology for NDA: 216635
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 216635
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 216635 | ANDA | Ascend Laboratories, LLC | 67877-772 | 67877-772-58 | 9 PACKET in 1 CARTON (67877-772-58) / 1 POWDER, FOR SOLUTION in 1 PACKET (67877-772-49) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 20, 2022 | TE: | AB | RLD: | No |
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