Details for New Drug Application (NDA): 204306
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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 204306
Tradename: | DICLOFENAC SODIUM |
Applicant: | Aurolife Pharma Llc |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204306
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 204306
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 204306 | ANDA | GERI-CARE PHARMACEUTICAL CORP | 57896-147 | 57896-147-01 | 1 TUBE in 1 CARTON (57896-147-01) / 100 g in 1 TUBE |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 204306 | ANDA | Aurohealth LLC | 58602-604 | 58602-604-07 | 1 TUBE in 1 CARTON (58602-604-07) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | May 6, 2019 | TE: | RLD: | No |
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