Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017938
Company: ENDO PHARMS

Products on NDA 017938

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOBAN	MOLINDONE HYDROCHLORIDE	20MG/ML	CONCENTRATE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017938

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/1979	ORIG-1	Approval	Type 3 - New Dosage Form	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
01/15/2002	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/2001	SUPPL-22	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf
08/21/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/25/1996	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1995	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1995	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1995	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/21/1984	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/19/1982	SUPPL-7	Labeling		Label is not available on this site.
11/16/1981	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/24/1981	SUPPL-3	Labeling		Label is not available on this site.
01/05/1981	SUPPL-2	Labeling		Label is not available on this site.