Drugs@FDA: FDA Approved Drug Products

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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 BX Yes No
ABSORICA ISOTRETINOIN 20MG CAPSULE;ORAL Prescription BX Yes No
ABSORICA ISOTRETINOIN 30MG CAPSULE;ORAL Prescription BX Yes No
ABSORICA ISOTRETINOIN 40MG CAPSULE;ORAL Prescription BX Yes Yes
ABSORICA ISOTRETINOIN 25MG CAPSULE;ORAL Prescription None Yes No
ABSORICA ISOTRETINOIN 35MG CAPSULE;ORAL Prescription None 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
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
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

There are no Therapeutic Equivalents.

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