Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040167
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG TABLET;ORAL Over-the-counter None 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
09/18/1996 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
03/06/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

10/09/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/02/2009 SUPPL-33 Labeling

Label is not available on this site.

07/14/2008 SUPPL-31 Labeling

Label is not available on this site.

09/10/2002 SUPPL-6 Labeling

Label is not available on this site.

10/04/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

10/04/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/21/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/10/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/10/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DOXYLAMINE SUCCINATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 25MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG TABLET;ORAL Over-the-counter No 040564 LNK
DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG TABLET;ORAL Over-the-counter No 040167 PERRIGO
UNISOM DOXYLAMINE SUCCINATE 25MG TABLET;ORAL Over-the-counter Yes 018066 CHATTEM

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