Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125511
Company: NPS PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NATPARA PARATHYROID HORMONE 25MCG INJECTABLE;INJECTION Prescription TBD TBD No
NATPARA PARATHYROID HORMONE 50MCG INJECTABLE;INJECTION Prescription TBD TBD No
NATPARA PARATHYROID HORMONE 75MCG INJECTABLE;INJECTION Prescription TBD TBD No
NATPARA PARATHYROID HORMONE 100MCG INJECTABLE;INJECTION Prescription TBD TBD 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
01/23/2015 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125511s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125511Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2016 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125511s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s004ltr.pdf
09/29/2016 SUPPL-2 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/15/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125511s004lbl.pdf
01/23/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125511s000lbl.pdf

NATPARA

There are no Therapeutic Equivalents.

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