Miconazole Nitrate
Miconazole Nitrate Vaginal Suppositories USP, 200 mg PHYSICIAN’S INSERT Rx only
Approved
Approval ID
aa9e250b-f317-42cb-b8d2-e85de56f4ef7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2020
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0472-1738
Application NumberANDA073508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miconazole Nitrate
Product Specifications
Route of AdministrationVAGINAL
Effective DateOctober 21, 2020
FDA Product Classification
INGREDIENTS (2)
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
MICONAZOLE NITRATEActive
Quantity: 200 mg in 1 1
Code: VW4H1CYW1K
Classification: ACTIB