Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020532
Company: STAND HOMEOPATH

Products on NDA 020532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVY BLOCK	BENTOQUATAM	5%	LOTION;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020532Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/16/2001	SUPPL-8	Labeling		Label is not available on this site.
12/09/1998	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1998	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/13/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/25/1998	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/16/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/1996	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

IVY BLOCK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IVY BLOCK	BENTOQUATAM	5%	LOTION;TOPICAL	Over-the-counter	Yes	020532	STAND HOMEOPATH