Drugs@FDA: FDA Approved Drug Products

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

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

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