Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021665
Company: AMPHASTAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPHADASE HYALURONIDASE 150 UNITS/ML INJECTABLE;INJECTION 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
10/26/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-665_Amphadase.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/28/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021665s005ltr.pdf
11/03/2005 SUPPL-2 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf
11/03/2005 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf
11/03/2005 SUPPL-2 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf
11/03/2005 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf
10/26/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf

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