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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012462
Company: PFIZER

Products on NDA 012462

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012462

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1960	ORIG-1	Approval	Type 4 - New Combination	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
02/12/2018	SUPPL-48	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012462Orig1s048ltr.pdf
10/05/2017	SUPPL-45	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012462s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012462Orig1s045ltr.pdf
04/28/2006	SUPPL-42	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012462s042, 012699s036LTR.pdf
06/07/1996	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
02/18/1994	SUPPL-40	Labeling		Label is not available on this site.
04/23/1991	SUPPL-39	Labeling		Label is not available on this site.
03/12/1987	SUPPL-38	Labeling		Label is not available on this site.
06/04/1986	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
04/07/1986	SUPPL-36	Labeling		Label is not available on this site.
03/01/1984	SUPPL-35	Labeling		Label is not available on this site.
12/21/1983	SUPPL-34	Labeling		Label is not available on this site.
04/07/1983	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
03/04/1982	SUPPL-31	Labeling		Label is not available on this site.
12/30/1980	SUPPL-30	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/08/1981	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/22/1979	SUPPL-28	Labeling		Label is not available on this site.
11/05/1979	SUPPL-27	Labeling		Label is not available on this site.
02/28/1977	SUPPL-26	Labeling		Label is not available on this site.
02/28/1977	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 012462

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2018	SUPPL-48	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf
02/12/2018	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf
10/05/2017	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012462s045lbl.pdf

Therapeutic Equivalents for NDA 012462

LOMOTIL

TABLET;ORAL; 0.025MG;2.5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	086727	ANI PHARMS
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	210819	BAYSHORE PHARMS LLC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	207128	CHARTWELL RX
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	085372	LANNETT
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	213413	LEADING
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	085762	MYLAN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	213335	SPECGX LLC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	210571	UPSHER SMITH LABS
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	No	AA	211362	WINDER LABS LLC
LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	Yes	AA	012462	PFIZER

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