Details for New Drug Application (NDA): 076201
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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 076201
Tradename: | DICLOFENAC SODIUM |
Applicant: | Dexcel Ltd |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 076201
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 076201
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | TABLET, EXTENDED RELEASE;ORAL | 076201 | ANDA | Lannett Company, Inc. | 0527-2170 | 0527-2170-37 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2170-37) |
DICLOFENAC SODIUM | diclofenac sodium | TABLET, EXTENDED RELEASE;ORAL | 076201 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-953 | 42799-953-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 6, 2002 | TE: | AB | RLD: | No |
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