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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211913
Company: SUN PHARM

REMS

Products on NDA 211913

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211913

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	New Combination and New Formulation or New Manufacturer	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
07/18/2023	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021951s024,211913s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021951Orig1s024;211913Orig1s011ltr.pdf
03/24/2023	SUPPL-10	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021951Orig1s022,211913Orig1s010ltr.pdf
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

Labels for NDA 211913

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021951s024,211913s011lbl.pdf
07/18/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021951s024,211913s011lbl.pdf
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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