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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021876
Company: DUCHESNAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLEGIS DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/08/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2022 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021876Orig1s016ltr.pdf
06/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021876Orig1s013ltr.pdf
03/10/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/23/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/16/2014 SUPPL-6 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf
11/24/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/30/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/28/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/30/2013 SUPPL-2 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
01/29/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2022 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
06/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf
09/30/2013 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
04/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf

DICLEGIS

TABLET, DELAYED RELEASE;ORAL; 10MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLEGIS DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 021876 DUCHESNAY
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 205811 ACTAVIS LABS FL INC
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 207825 MYLAN PHARMS INC
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 208518 PAR PHARM INC
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