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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210452
Company: GLAND

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
09/26/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210452Orig1s000ltr.pdf

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 210452 GLAND
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
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