Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209252
Company: GLENMARK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% 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
03/14/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

GEL;TOPICAL; 5%;EQ 1% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription Yes AB 050756 BAUSCH
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 209252 GLENMARK PHARMS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 065443 MYLAN PHARMS INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 202440 PERRIGO UK FINCO
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 208776 TARO
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 204087 TOLMAR

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