Details for New Drug Application (NDA): 213040
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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. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 213040
Tradename: | DICLOFENAC SODIUM |
Applicant: | Aurolife Pharma Llc |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213040
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 213040
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 213040 | ANDA | Aurolife Pharma LLC | 13107-269 | 13107-269-47 | 1 BOTTLE in 1 CARTON (13107-269-47) / 112 g in 1 BOTTLE |
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 213040 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8541 | 68788-8541-1 | 1 BOTTLE in 1 CARTON (68788-8541-1) / 112 g in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
Approval Date: | Feb 3, 2023 | TE: | AB | RLD: | No |
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