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ACANYA از شرکت BAUSCH

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ACANYA از شرکت BAUSCH

New Drug Application (NDA): 050819

Company: BAUSCH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACANYA BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 2.5%;EQ 1.2% BASE GEL;TOPICAL Prescription

AB

Yes Yes
ONEXTON BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 3.75%;EQ 1.2% BASE GEL;TOPICAL Prescription

None

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/23/2008 ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050819s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819_acanya_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_SumR_P1.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2020 SUPPL-24 Labeling-Patient Package Insert, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf

02/21/2020 SUPPL-23 Labeling-Patient Package Insert, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf

03/25/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/19/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/24/2014 SUPPL-12 Efficacy-New Dosing Regimen

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/050819Orig1s012.pdf

03/18/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-10 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s010ltr.pdf

12/18/2012 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/18/2010 SUPPL-3 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s003ltr.pdf

06/23/2010 SUPPL-2 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2020 SUPPL-24

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020 SUPPL-24

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020 SUPPL-23

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020 SUPPL-23

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
11/24/2014 SUPPL-12

Efficacy-New Dosing Regimen

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf
02/28/2014 SUPPL-10

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf
10/18/2010 SUPPL-3

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf
06/23/2010 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf
10/23/2008 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf

ACANYA

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

ONEXTON

There are no Therapeutic Equivalents.

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