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VITAMIN D

ANDA

ERGOCALCIFEROL | A080747 | CHASE CHEMICAL CO LP

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Cover Page - Rutgers-The State University of New Jersey - Citizen Petition FDA-2006-P-0208 · 6 docket documents Rutgers scientists including Harold L. Newmark, Robert P. Heaney, Paul Lachance, and Sue Shapses filed this citizen petition pursuant to 21 CFR 10.30 requesting that the FDA amend enrichment regulations to add Vitamin D as a mandatory sixth nutrient in cereal grain products, joining the existing fiv	Other	2009-04-22	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SYNTHESIA ASERGOCALCIFEROL USP

DMF 111421994

FORMOSA LABORATORIES INCERGOCALCIFEROL

DMF 241892010

SICHUAN PROVINCE YUXIN PHARMACEUTICAL CO LTDERGOCALCIFEROL USP

DMF 361262021

SYNTHESIA ASInactiveERGOCALCIFEROL

DMF 218392008

ALP PHARM BEIJING CO LTDInactiveERGOCALCIFEROL USP

DMF 231552009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 50,000 IU

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.