Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076242
Company: HIKMA

Products on ANDA 076242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCITRIOL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076242

CALCITRIOL

SOLUTION;ORAL; 1MCG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITRIOL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	No	AA	076242	HIKMA
CALCITRIOL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	No	AA	203973	PATRIN
CALCITRIOL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	No	AA	209798	RISING
ROCALTROL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	Yes	AA	021068	SS PHARMA