Drugs@FDA: FDA Approved Drug Products

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

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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