Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012699
Company: GD SEARLE LLC

Products on NDA 012699

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG/5ML;2.5MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012699

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/1961	ORIG-1	Approval	Type 3 - New Dosage Form	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
04/28/2006	SUPPL-36	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf
02/18/1994	SUPPL-35	Labeling		Label is not available on this site.
04/23/1991	SUPPL-34	Labeling		Label is not available on this site.
03/12/1987	SUPPL-33	Labeling		Label is not available on this site.
04/07/1986	SUPPL-32	Labeling		Label is not available on this site.
03/01/1984	SUPPL-31	Labeling		Label is not available on this site.
12/21/1983	SUPPL-30	Labeling		Label is not available on this site.
04/28/1983	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
03/04/1982	SUPPL-26	Labeling		Label is not available on this site.
11/05/1979	SUPPL-25	Labeling		Label is not available on this site.
03/01/1977	SUPPL-24	Labeling		Label is not available on this site.
11/22/1976	SUPPL-23	Labeling		Label is not available on this site.
07/28/1976	SUPPL-21	Labeling		Label is not available on this site.