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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011483
Company: SUN PHARM INDUSTRIES

Medication Guide

REMS

Products on NDA 011483

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNALGOS-DC	ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE	356.4MG;30MG;16MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/1958	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-37	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011483s037lbl.pdf
10/31/2024	SUPPL-36	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011483Orig1s036ltr.pdf
12/15/2023	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011483s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011483Orig1s035ltr.pdf
04/28/2021	SUPPL-34	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011483Orig1s034ltr.pdf
10/07/2019	SUPPL-33	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011483s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011483Orig1s033ltr.pdf
09/18/2018	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf
09/18/2018	SUPPL-31	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf
08/29/2017	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011483Orig1s030ltr.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011483Orig1s029ltr.pdf
05/09/2013	SUPPL-27	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011483Orig1s027ltr.pdf
05/11/2006	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
03/13/2006	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/31/2001	SUPPL-15	Labeling		Label is not available on this site.
08/05/1987	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/03/1987	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/06/1983	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/06/1983	SUPPL-11	Labeling		Label is not available on this site.

Labels for NDA 011483

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-37	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011483s037lbl.pdf
11/21/2024	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011483s037lbl.pdf
12/15/2023	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011483s035lbl.pdf
04/28/2021	SUPPL-34	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf
04/28/2021	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf
10/07/2019	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011483s033lbl.pdf
10/07/2019	SUPPL-33	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011483s033lbl.pdf
09/18/2018	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf
09/18/2018	SUPPL-31	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf
08/29/2017	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf
08/29/2017	SUPPL-30	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
12/16/2016	SUPPL-29	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
05/09/2013	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf
05/09/2013	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf

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