Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075765
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription AB No No
CALCITRIOL CALCITRIOL 0.5MCG 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
10/12/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75765.ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/24/2008 SUPPL-4 Labeling

Label is not available on this site.

02/21/2007 SUPPL-3 Labeling

Label is not available on this site.

09/18/2002 SUPPL-2 Labeling

Label is not available on this site.

04/16/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

CALCITRIOL

CAPSULE;ORAL; 0.25MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 203289 AMNEAL PHARMS
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 091174 BIONPHARMA INC
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 076917 HIKMA
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 091356 STRIDES PHARMA
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 075765 TEVA
ROCALTROL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription Yes AB 018044 VALIDUS PHARMS

CAPSULE;ORAL; 0.5MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCITRIOL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription No AB 203289 AMNEAL PHARMS
CALCITRIOL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription No AB 091174 BIONPHARMA INC
CALCITRIOL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription No AB 091356 STRIDES PHARMA
CALCITRIOL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription No AB 075765 TEVA
ROCALTROL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription Yes AB 018044 VALIDUS PHARMS

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