An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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-Medication Guide, Labeling-Package Insert	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-Medication Guide, Labeling-Package Insert	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-Medication Guide, Labeling-Package Insert, 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
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011483s033lbl.pdf
10/07/2019	SUPPL-33	Labeling-Package Insert	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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf
08/29/2017	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.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
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

Top