Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076917
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCITRIOL CALCITRIOL 0.25MCG 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
03/27/2006 ORIG-1 Approval

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 091356 STRIDES PHARMA
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 075765 TEVA
CALCITRIOL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription No AB 076917 WEST-WARD PHARMS INT
ROCALTROL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription Yes AB 018044 VALIDUS PHARMS

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