Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007959
Company: PAI HOLDINGS PHARM

Products on NDA 007959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENSILON	EDROPHONIUM CHLORIDE	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
TENSILON PRESERVATIVE FREE	EDROPHONIUM CHLORIDE	10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007959

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/1951	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2003	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf
10/01/1997	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/2002	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7959s013s015.pdf
08/09/1993	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/03/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/07/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/05/1983	SUPPL-6	Labeling		Label is not available on this site.