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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200926
Company: SANDOZ

Products on ANDA 200926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/2014	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200926Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/13/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/04/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 200926

DOXERCALCIFEROL

INJECTABLE;INJECTION; 4MCG/2ML (2MCG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215810	ALEMBIC
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208975	AMNEAL
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213717	EUGIA PHARMA
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210452	GLAND PHARMA LTD
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091101	HIKMA
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	208614	HOSPIRA
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210801	LUPIN LTD
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	211670	MEITHEAL
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091333	SANDOZ
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200926	SANDOZ
HECTOROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	021027	SANOFI

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