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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019678
Company: PHARMOBEDIENT

Products on NDA 019678

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	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019678

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 5 - New Formulation or New Manufacturer	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
10/28/2025	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019678Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019678Orig1s010ltr.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.
04/20/1994	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 019678

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2025	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019678Orig1s010lbl.pdf
10/28/2025	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019678Orig1s010lbl.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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