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FDA NDA · NDA208614

DOXERCALCIFEROL

Sponsor: HOSPIRA

APPLICATION
NDA208614
TYPE
NDA
ORIGINAL APPROVAL
2018-07-24
LATEST ACTION
2019-08-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOXERCALCIFEROL · ReferenceDiscontinued
DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) · INJECTABLE · INJECTION
DOXERCALCIFEROL · ReferenceDiscontinued
DOXERCALCIFEROL 10MCG/5ML (2MCG/ML) · INJECTABLE · INJECTION

Approval history

2019-08-28Labeling · Supplement 2 · standard — Label ↗AP
2018-07-24Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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