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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085372
Company: LANNETT

Products on ANDA 085372

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085372

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/1978	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2017	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/29/2008	SUPPL-11	Labeling		Label is not available on this site.
03/28/2007	SUPPL-9	Labeling		Label is not available on this site.
08/26/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/2000	SUPPL-6	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/26/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/2000	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/10/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
08/14/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2000	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 085372

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

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	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	213335	SPECGX LLC
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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