Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091433
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE;ORAL Prescription AB No No
DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription AB No No
DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE;ORAL Prescription AB 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
01/14/2014 ORIG-2 Approval

Label is not available on this site.

09/23/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091433s000ltr.pdf

DOXERCALCIFEROL

CAPSULE;ORAL; 0.5MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE;ORAL Prescription No AB 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
HECTOROL DOXERCALCIFEROL 0.5MCG CAPSULE;ORAL Prescription Yes AB 020862 SANOFI

CAPSULE;ORAL; 1MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription No AB 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
HECTOROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription Yes AB 020862 SANOFI

CAPSULE;ORAL; 2.5MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE;ORAL Prescription No AB 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
HECTOROL DOXERCALCIFEROL 2.5MCG CAPSULE;ORAL Prescription Yes AB 020862 SANOFI

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