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

Abbreviated New Drug Application (ANDA): 073508
Company: ACTAVIS PHARMA

Products on ANDA 073508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MICONAZOLE NITRATE	MICONAZOLE NITRATE	200MG	SUPPOSITORY;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/1993	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
01/08/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
01/09/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/28/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/11/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/15/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/30/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073508

MICONAZOLE NITRATE

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