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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021642
Company: ENDO PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASCOBAL CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription None 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
01/31/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021642ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021642s000_NascobalTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/17/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/06/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/06/2014 SUPPL-20 Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021642Orig1s020.pdf
12/07/2018 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021642s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021642Orig1s019Ltr.pdf
11/15/2012 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/08/2011 SUPPL-15 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021642Orig1s015ltr.pdf
06/11/2014 SUPPL-11 Labeling

Label is not available on this site.

09/15/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021642s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021642s019lbl.pdf
06/06/2014 SUPPL-20 Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf
12/08/2011 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf
09/15/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf
01/31/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf
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