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FDA NDA · NDA021318

TERIPARATIDE

Sponsor: LILLY

APPLICATION
NDA021318
TYPE
NDA
ORIGINAL APPROVAL
2002-11-26
LATEST ACTION
2024-07-24
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

FORTEO · ReferencePrescription
TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) · SOLUTION · SUBCUTANEOUS
FORTEODiscontinued
TERIPARATIDE 0.75MG/3ML (0.25MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-07-24Labeling · Supplement 57 · standard — Label ↗AP
2021-09-07Labeling · Supplement 56 · standard — Letter ↗AP
2020-11-16Efficacy · Supplement 54 · standard — Letter ↗AP
2020-04-06Labeling · Supplement 53 · standard — Letter ↗AP
2019-10-03Labeling · Supplement 52 · standard — Label ↗AP
2017-04-28REMS · Supplement 51 — Letter ↗AP
2015-11-23Manufacturing (CMC) · Supplement 44 · standardAP
2014-09-12Manufacturing (CMC) · Supplement 41 · standardAP
2014-08-13Manufacturing (CMC) · Supplement 40 · standardAP
2014-04-11Manufacturing (CMC) · Supplement 39 · standardAP
2014-03-05Manufacturing (CMC) · Supplement 37 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 38 · standardAP
2013-08-30REMS · Supplement 36 — Letter ↗AP
2013-08-02Manufacturing (CMC) · Supplement 35 · standardAP
2013-03-13Manufacturing (CMC) · Supplement 33 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 32 · standardAP
2012-03-13Labeling · Supplement 27 · standard — Letter ↗AP
2011-08-10Labeling · Supplement 26 · unknown — Letter ↗AP
2009-07-22Efficacy · Supplement 12 · standard — Letter ↗AP
2008-06-25Manufacturing (CMC) · Supplement 16 — Review ↗AP
2008-02-28Labeling · Supplement 15 · standard — Letter ↗AP
2007-05-19Labeling · Supplement 9 · standard — Label ↗AP
2004-09-03Labeling · Supplement 4 · standard — Label ↗AP
2004-06-02Labeling · Supplement 2 · standard — Letter ↗AP
2002-11-26Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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