Details for New Drug Application (NDA): 208198
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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 208198
Tradename: | DICLOFENAC SODIUM |
Applicant: | Amneal |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208198
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 208198
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 208198 | ANDA | Amneal Pharmaceuticals LLC | 65162-683 | 65162-683-12 | 1 BOTTLE in 1 CARTON (65162-683-12) / 112 g in 1 BOTTLE |
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 208198 | ANDA | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0335 | 80425-0335-1 | 1 BOTTLE in 1 CARTON (80425-0335-1) / 112 g in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
Approval Date: | Aug 18, 2022 | TE: | AB | RLD: | No |
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