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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125511
Company: NPS PHARMS INC

Medication Guide

REMS

Summary Review

Products on BLA 125511

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125511

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
04/07/2022	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125511s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125511Orig1s028ltr.pdf
06/05/2020	SUPPL-21	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125511Orig1s021ltr.pdf
07/01/2020	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125511s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125511Orig1s020replacementltr.pdf
12/17/2018	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125511Orig1s016ltr.pdf
09/27/2018	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125511Orig1s014ltr.pdf
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

Labels for BLA 125511

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2022	SUPPL-28	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125511s028lbl.pdf
04/07/2022	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125511s028lbl.pdf
04/07/2022	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125511s028lbl.pdf
07/01/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125511s020lbl.pdf
12/17/2018	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf
09/27/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf
09/27/2018	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf
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

Therapeutic Equivalents for BLA 125511

NATPARA

There are no Therapeutic Equivalents.

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