Details for New Drug Application (NDA): 202027
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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 202027
Tradename: | DICLOFENAC SODIUM |
Applicant: | Apotex |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 202027
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 202027 | ANDA | V2 Pharma, LLC | 72835-201 | 72835-201-02 | 1 KIT in 1 CARTON (72835-201-02) * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 1.5% | ||||
Approval Date: | May 27, 2014 | TE: | RLD: | No |
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