GIANVI
Gianvi™(drospirenone and ethinyl estradiol tablets)Rev. D 6/201011001685
Approved
Approval ID
78f2664f-3de8-4e58-a860-1b5abd6eb7d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
drospirenone and ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6162
Application NumberANDA078515
Product Classification
M
Marketing Category
C73584
G
Generic Name
drospirenone and ethinyl estradiol
Product Specifications
Effective DateOctober 22, 2010
FDA Product Classification