Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205128
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 207194 ANDA REPOSITORY
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 2.5%;EQ 1.2% BASE GEL;TOPICAL Prescription No AB 205397 PERRIGO ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 2.5%;EQ 1.2% BASE GEL;TOPICAL Prescription No AB 206575 TARO

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