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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011702
Company: SUN PHARM INDUSTRIES

Products on NDA 011702

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EQUAGESIC	ASPIRIN; MEPROBAMATE	325MG;200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011702

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/1960	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
04/28/2021	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011702s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011702Orig1s040ltr.pdf
03/22/2006	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
05/19/2003	SUPPL-36	Labeling		Label is not available on this site.
01/27/1988	SUPPL-33	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/1988	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/08/1987	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/12/1986	SUPPL-30	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/29/1985	SUPPL-29	Labeling		Label is not available on this site.
12/29/1983	SUPPL-28	Labeling		Label is not available on this site.
09/19/1983	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
03/06/1981	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/20/1978	SUPPL-20	Labeling		Label is not available on this site.
12/15/1978	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
12/15/1978	SUPPL-18	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/15/1978	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/22/1975	SUPPL-5	Labeling		Label is not available on this site.

Labels for NDA 011702

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011702s040lbl.pdf

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