Drugs@FDA: FDA Approved Drug Products

Abbreviated New Drug Application (ANDA): 080704
Company: BIONPHARMA INC

Products on ANDA 080704

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080704

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	Note
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.

Therapeutic Equivalents for ANDA 080704

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