Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086727
Company: ANI PHARMS

Products on ANDA 086727

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 086727

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1979	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
09/19/2025	SUPPL-55	Labeling-Package Insert		Label is not available on this site.
10/11/2024	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
06/19/2007	SUPPL-44	Manufacturing (CMC)-Facility		Label is not available on this site.
07/29/2002	SUPPL-38	Manufacturing (CMC)-Facility		Label is not available on this site.
09/12/2001	SUPPL-36	Manufacturing (CMC)-Facility		Label is not available on this site.
08/15/2000	SUPPL-35	Manufacturing (CMC)-Facility		Label is not available on this site.
05/05/2000	SUPPL-34	Labeling		Label is not available on this site.
05/05/2000	SUPPL-33	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/05/2000	SUPPL-32	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-31	Manufacturing (CMC)-Facility		Label is not available on this site.
11/18/1999	SUPPL-30	Manufacturing (CMC)-Facility		Label is not available on this site.
11/18/1999	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
11/18/1999	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/1999	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/24/1998	SUPPL-26	Labeling		Label is not available on this site.
01/20/1988	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
01/20/1988	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/14/1987	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/14/1987	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086727

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	086727	ANI PHARMS
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	210819	UNICHEM
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