Details for New Drug Application (NDA): 021005
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The generic ingredient in SOLARAZE is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 021005
Tradename: | SOLARAZE |
Applicant: | Fougera Pharms |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL;TOPICAL | Strength | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 16, 2000 | TE: | RLD: | Yes |
Expired US Patents for NDA 021005
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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