ADAPALENE AND BENZOYL PEROXIDE از شرکت ACTAVIS MID ATLANTIC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADAPALENE AND BENZOYL PEROXIDE از شرکت ACTAVIS MID ATLANTIC

Abbreviated New Drug Application (ANDA): 203790

Company: ACTAVIS MID ATLANTIC

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
09/30/2015 ORIG-1 Approval

Letter (PDF)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000TAltr.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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