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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019677
Company: MYLAN INSTITUTIONAL

Products on NDA 019677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENLON-PLUS	ATROPINE SULFATE; EDROPHONIUM CHLORIDE	0.14MG/ML;10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/1991	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
04/01/2009	SUPPL-6	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019677s006ltr.pdf
12/06/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005ltr.pdf
04/18/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/26/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/11/1994	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2009	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf
12/06/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf

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