Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205128
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | 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 |
---|---|---|---|---|---|---|---|
06/19/2015 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
GEL;TOPICAL; 2.5%;EQ 1.2% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | Yes | AB | 050819 | BAUSCH |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 205128 | ACTAVIS LABS UT INC |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 205397 | PADAGIS ISRAEL |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 206575 | TARO |