Angeliq
ANGELIQ TABLETS(Drospirenone and Estradiol) 0.5 mg/1 mg
Approved
Approval ID
01a8bfdf-0fac-4e86-a299-daf64a2e885e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2009
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 estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6184
Application NumberNDA021355
Product Classification
M
Marketing Category
C73594
G
Generic Name
drospirenone and estradiol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2010
FDA Product Classification
INGREDIENTS (11)
DROSPIRENONEActive
Quantity: 0.5 mg in 1 1
Code: N295J34A25
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ESTRADIOLActive
Quantity: 1 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT