Details for New Drug Application (NDA): 050819
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NDA 050819 describes ONEXTON, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ONEXTON profile page.
The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 050819
| Tradename: | ONEXTON |
| Applicant: | Bausch |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 9 |
Pharmacology for NDA: 050819
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 050819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819 | NDA | Bausch Health US, LLC | 0187-3050 | 0187-3050-35 | 3.5 g in 1 TUBE (0187-3050-35) |
| ONEXTON | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819 | NDA | Bausch Health US, LLC | 0187-3050 | 0187-3050-35 | 3.5 g in 1 TUBE (0187-3050-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 2.5%;EQ 1.2% BASE | ||||
| Approval Date: | Oct 23, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,220,049 | Patent Expiration: | Jun 3, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER | ||||||||
| Patent: | 10,624,918 | Patent Expiration: | Jun 3, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER | ||||||||
| Patent: | 8,288,434 | Patent Expiration: | Aug 5, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACNE | ||||||||
Expired US Patents for NDA 050819
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | 5,733,886 | ⤷ Get Started Free |
| Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | 6,117,843 | ⤷ Get Started Free |
| Bausch | ONEXTON | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-002 | Nov 24, 2014 | 5,733,886 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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