Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018044
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROCALTROL CALCITRIOL 0.25MCG CAPSULE;ORAL Prescription AB Yes No
ROCALTROL CALCITRIOL 0.5MCG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/17/1978 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2010 SUPPL-38 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018044s038ltr.pdf
07/07/2004 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf
11/12/2001 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/2001 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/01/2002 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf
12/15/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-25 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18044s25ltr.pdf
10/22/1996 SUPPL-24 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf
05/26/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1991 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1990 SUPPL-19 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf
04/08/1991 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf
04/27/1988 SUPPL-17 Labeling

Label is not available on this site.

04/27/1988 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1986 SUPPL-15 Labeling

Label is not available on this site.

12/20/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/22/1986 SUPPL-12 Efficacy

Label is not available on this site.

08/20/1984 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1983 SUPPL-9 Labeling

Label is not available on this site.

04/22/1982 SUPPL-8 Labeling

Label is not available on this site.

12/10/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/22/1982 SUPPL-4 Efficacy

Label is not available on this site.

11/09/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

ROCALTROL

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 204556 SUN PHARM
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

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 204556 SUN PHARM
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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