Premphase
These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE (conjugated estrogens plus medroxyprogesterone acetate tablets)Initial U.S. Approval: 1995
Approved
Approval ID
701acf2c-fffe-451a-9b94-82d825e5a47c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 26, 2012
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.
conjugated estrogens and medroxyprogesterone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3800
Application NumberANDA075796
Product Classification
M
Marketing Category
C73584
G
Generic Name
conjugated estrogens and medroxyprogesterone acetate
Product Specifications
Effective DateNovember 1, 2012
FDA Product Classification