Orange Book product · Brand (NDA)
ONEXTON
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
At a glance
Nov 24, 2014
Approved
Brand (NDA)
Application
AB
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 2014
11 yr 9 mo ago
Today
Patent 10137142 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 10220049 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 9504704 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 9504704 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 9504704 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 9504704 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 9561208 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Strength
3.75%;EQ 1.2% BASE
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 050819
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2002DUACBrand (NDA)
NDA 050741 · STIEFEL
- 2000BENZACLINBrand (NDA)
NDA 050756 · BAUSCH
- 2024CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209610 · PADAGIS ISRAEL
- 2021CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 212433 · ENCUBE
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 205397 · PADAGIS ISRAEL
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 207194 · ENCUBE
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206575 · SUN PHARMA CANADA
- 2019CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 209252 · GLENMARK SPECLT
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 210794 · ZYDUS PHARMS
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 208683 · SUN PHARMA CANADA
- 2018CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 208776 · SUN PHARMA CANADA
- 2017CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGeneric (ANDA)
ANDA 206218 · SUN PHARMA CANADA
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10137142 | Jun 03, 2029 | in 3 yr | ProductU-916 |
| 10220049 | Jun 03, 2029 | in 3 yr | ProductU-916 |
| 9504704 | Jun 03, 2029 | in 3 yr | ProductU-134 |
| 9504704 | Jun 03, 2029 | in 3 yr | ProductU-818 |
| 9504704 | Jun 03, 2029 | in 3 yr | ProductU-916 |
| 9504704 | Jun 03, 2029 | in 3 yr | ProductU-124 |
| 9561208 | Jun 03, 2029 | in 3 yr | ProductU-916 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-818 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-124 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-134 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-1033 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-921 |
| 8288434 | Aug 05, 2029 | in 3 yr 2 mo | ProductU-916 |
