Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 003444
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DRISDOL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription AA 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
01/11/1941 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2003 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/03444slr020ltr.pdf
04/03/1992 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/14/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/14/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1986 SUPPL-16 Labeling

Label is not available on this site.

03/11/1985 SUPPL-15 Labeling

Label is not available on this site.

03/11/1985 SUPPL-13 Labeling

Label is not available on this site.

07/07/1980 SUPPL-12 Labeling

Label is not available on this site.

01/19/1978 SUPPL-10 Labeling

Label is not available on this site.

12/07/1976 SUPPL-9 Labeling

Label is not available on this site.

12/07/1976 SUPPL-8 Labeling

Label is not available on this site.

06/22/1976 SUPPL-7 Labeling

Label is not available on this site.

03/04/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1975 SUPPL-5 Labeling

Label is not available on this site.

DRISDOL

CAPSULE;ORAL; 50,000 IU
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRISDOL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription Yes AA 003444 US PHARM HOLDINGS
ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription No AA 040833 ORIT LABS LLC
ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription No AA 091004 SIGMAPHARM LABS LLC
ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription No AA 090455 STRIDES PHARMA
ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription No AA 040865 SUN PHARM INDS INC
VITAMIN D ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription No AA 080704 BIONPHARMA INC

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