Drugs@FDA: FDA-Approved Drugs

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

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

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.

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 203929 AKORN
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208974 AMNEAL
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 INC
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 INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 200926 SANDOZ INC
HECTOROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 021027 SANOFI

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