Drugs@FDA: FDA Approved Drug Products

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

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 INC
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 085372 LANNETT
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 040357 PAR PHARM
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription No AA 210571 UPSHER SMITH LABS
LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG TABLET;ORAL Prescription Yes AA 012462 GD SEARLE LLC

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