ADAPALENE AND BENZOYL PEROXIDE از شرکت TARO

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ADAPALENE AND BENZOYL PEROXIDE از شرکت TARO

Abbreviated New Drug Application (ANDA): 206959

Company: TARO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% 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
01/24/2018 ORIG-2 Approval

Labeling

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206959Orig1s000ltr.pdf

01/24/2018 ORIG-1 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206959Orig1s000TAltr.pdf

ADAPALENE AND BENZOYL PEROXIDE

GEL;TOPICAL; 0.1%;2.5%

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 203790 ACTAVIS MID ATLANTIC
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 208108 GLENMARK PHARMS LTD
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 205033 PADAGIS ISRAEL
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 206959 TARO
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 206164 TOLMAR
EPIDUO ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription Yes AB 022320 GALDERMA LABS LP
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