Benzoyl - Generic Drug Details
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Generic filers with tentative approvals for BENZOYL
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 3.75%; EQ 1.2% BASE | GEL;TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for benzoyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 205397-001 | Sep 9, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Mayne Pharma | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 12,491,163 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | AB | RX | Yes | Yes | 9,078,870 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Bausch | ONEXTON | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-002 | Nov 24, 2014 | AB | RX | Yes | Yes | 10,137,142 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Mayne Pharma | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 12,257,348 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
