Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206218
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/15/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
GEL;TOPICAL; 5%;1.2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 212433 | ENCUBE |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 090979 | PADAGIS ISRAEL |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 206218 | TARO |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 210794 | ZYDUS PHARMS |
DUAC | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | Yes | AB | 050741 | STIEFEL |