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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021068
Company: SS PHARMA

Products on NDA 021068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROCALTROL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021068.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/07/2004	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf
02/01/2002	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf

Labels for NDA 021068

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf

Therapeutic Equivalents for NDA 021068

ROCALTROL

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

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