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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211913
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABSORICA LD ISOTRETINOIN 8MG CAPSULE;ORAL Prescription None Yes No
ABSORICA LD ISOTRETINOIN 16MG CAPSULE;ORAL Prescription None Yes No
ABSORICA LD ISOTRETINOIN 20MG CAPSULE;ORAL Discontinued None Yes No
ABSORICA LD ISOTRETINOIN 24MG CAPSULE;ORAL Prescription None Yes No
ABSORICA LD ISOTRETINOIN 28MG CAPSULE;ORAL Discontinued None Yes No
ABSORICA LD ISOTRETINOIN 32MG CAPSULE;ORAL 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
11/05/2019 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211913lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211913Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211913Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2022 SUPPL-9 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211913Orig1s009ltr.pdf
04/07/2022 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211913Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211913Orig1s005ltr.pdf
10/08/2021 SUPPL-4 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211913Orig1s004ltr.pdf
12/09/2020 SUPPL-3 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211913Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/07/2022 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211913Orig1s005lbl.pdf
11/05/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211913lbl.pdf
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