Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074721
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;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
12/29/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74721ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/17/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/14/2008 SUPPL-9 Labeling

Label is not available on this site.

06/26/2007 SUPPL-8 Labeling

Label is not available on this site.

06/05/2006 SUPPL-7 Labeling

Label is not available on this site.

08/15/2005 SUPPL-6 Labeling

Label is not available on this site.

04/30/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/30/2000 SUPPL-2 Labeling

Label is not available on this site.

DOXEPIN HYDROCHLORIDE

CONCENTRATE;ORAL; EQ 10MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 074721 LANNETT CO INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 071609 TEVA PHARMS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 071918 WOCKHARDT BIO AG

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