Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022402
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CODEINE SULFATE CODEINE SULFATE 15MG TABLET;ORAL Prescription AB Yes No
CODEINE SULFATE CODEINE SULFATE 30MG TABLET;ORAL Prescription AB Yes No
CODEINE SULFATE CODEINE SULFATE 60MG TABLET;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
07/16/2009 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022402s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402_codeine_sulfate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022402Orig1s009ltr.pdf
12/16/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022402Orig1s008ltr.pdf
05/09/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022402Orig1s006ltr.pdf
06/17/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/17/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022402s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/29/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf
12/16/2016 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf
12/16/2016 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf
05/09/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf
04/17/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf
07/16/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf

CODEINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CODEINE SULFATE CODEINE SULFATE 15MG TABLET;ORAL Prescription No AB 203046 LANNETT HOLDINGS INC
CODEINE SULFATE CODEINE SULFATE 15MG TABLET;ORAL Prescription Yes AB 022402 WEST-WARD PHARMS INT

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CODEINE SULFATE CODEINE SULFATE 30MG TABLET;ORAL Prescription No AB 203046 LANNETT HOLDINGS INC
CODEINE SULFATE CODEINE SULFATE 30MG TABLET;ORAL Prescription Yes AB 022402 WEST-WARD PHARMS INT

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CODEINE SULFATE CODEINE SULFATE 60MG TABLET;ORAL Prescription No AB 203046 LANNETT HOLDINGS INC
CODEINE SULFATE CODEINE SULFATE 60MG TABLET;ORAL Prescription Yes AB 022402 WEST-WARD PHARMS INT

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