Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080704
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITAMIN D ERGOCALCIFEROL 50,000 IU CAPSULE;ORAL Prescription AA 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
10/16/1978 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
07/24/2008 SUPPL-43 Labeling

Label is not available on this site.

10/24/2001 SUPPL-41 Labeling

Label is not available on this site.

10/24/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/2001 SUPPL-38 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/24/2001 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

09/09/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/31/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/24/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/24/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-27 Labeling

Label is not available on this site.

03/22/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/08/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

VITAMIN D

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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