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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013416
Company: BAUSCH

Products on NDA 013416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORGESIC	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	385MG;30MG;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
NORGESIC FORTE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	770MG;60MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/1964	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-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013416s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013416Orig1s030ltr.pdf
03/26/1999	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1997	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/1995	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
12/16/1993	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/30/1988	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
11/05/1993	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/1987	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/25/2002	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13416spd021ltr.pdf
01/31/1986	SUPPL-20	Labeling		Label is not available on this site.
07/27/1977	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/27/1977	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 013416

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013416s030lbl.pdf

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