Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 003444
Company: ESJAY PHARMA

Products on NDA 003444

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DRISDOL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 003444

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.

Therapeutic Equivalents for NDA 003444

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	ESJAY PHARMA
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	040833	CHARTWELL RX
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	090455	ONESOURCE SPECIALTY
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	204276	PURACAP PHARM LLC
VITAMIN D	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	080704	BIONPHARMA