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ABSORICA از شرکت SUN PHARM INDS INC

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ABSORICA از شرکت SUN PHARM INDS INC

New Drug Application (NDA): 021951

Company: SUN PHARM INDS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABSORICA ISOTRETINOIN 10MG CAPSULE;ORAL Prescription

AB2

Yes No
ABSORICA ISOTRETINOIN 20MG CAPSULE;ORAL Prescription

AB2

Yes No
ABSORICA ISOTRETINOIN 30MG CAPSULE;ORAL Prescription

AB2

Yes No
ABSORICA ISOTRETINOIN 40MG CAPSULE;ORAL Prescription

AB2

Yes Yes
ABSORICA ISOTRETINOIN 25MG CAPSULE;ORAL Prescription

AB2

Yes No
ABSORICA ISOTRETINOIN 35MG CAPSULE;ORAL Prescription

AB2

Yes 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
05/25/2012 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021951s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021951_absorica_toc.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2020 SUPPL-17 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021951Orig1s017replacementltr.pdf

01/24/2020 SUPPL-15 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021951Orig1s015ltr.pdf

08/31/2018 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s014ltr.pdf

11/07/2019 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021951Orig1s013ltr.pdf

04/23/2018 SUPPL-12 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s012ltr.pdf

05/02/2018 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s011ltr.pdf

06/17/2017 SUPPL-10 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021951Orig1s010ltr.pdf

07/08/2016 SUPPL-8 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s008ltr.pdf

02/04/2016 SUPPL-7 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s007ltr.pdf

12/23/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/03/2015 SUPPL-5 REMS-Modified

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021951Orig1s005ltr.pdf

10/20/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/15/2014 SUPPL-3 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s003ltr.pdf

07/30/2014 SUPPL-1 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2019 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf
08/31/2018 SUPPL-14

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf
08/31/2018 SUPPL-14

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf
05/02/2018 SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf
05/02/2018 SUPPL-11

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf
09/03/2015 SUPPL-5

REMS-Modified

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf
08/15/2014 SUPPL-3

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf
07/30/2014 SUPPL-1

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf
05/25/2012 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf

ABSORICA

CAPSULE;ORAL; 10MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 10MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

CAPSULE;ORAL; 20MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 20MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

CAPSULE;ORAL; 30MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 30MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

CAPSULE;ORAL; 40MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 40MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB2 213571 UPSHER SMITH LABS

CAPSULE;ORAL; 25MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 25MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 25MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL

CAPSULE;ORAL; 35MG

TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 35MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 35MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
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