An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018888
Company: MEDTECH PRODUCTS

Products on NDA 018888

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONISTAT 3	MICONAZOLE NITRATE	200MG	SUPPOSITORY;VAGINAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018888

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/1984	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/11/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/10/2013	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/07/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/12/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
09/22/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/07/1998	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/17/1988	SUPPL-6	Labeling		Label is not available on this site.
09/17/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/25/1986	SUPPL-4	Labeling		Label is not available on this site.
06/25/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/05/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018888

MONISTAT 3

SUPPOSITORY;VAGINAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICONAZOLE NITRATE	MICONAZOLE NITRATE	200MG	SUPPOSITORY;VAGINAL	Prescription	No	AB	073508	ACTAVIS PHARMA
MONISTAT 3	MICONAZOLE NITRATE	200MG	SUPPOSITORY;VAGINAL	Prescription	Yes	AB	018888	MEDTECH PRODUCTS

Top