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FDA Approval

Angeliq

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 29, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Drospirenone(0.5 mg in 1 1)
Estradiol(1 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Angeliq

Product Details

NDC Product Code
54868-6184
Application Number
NDA021355
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 1, 2010
Code: N295J34A25Class: ACTIBQuantity: 0.5 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
EstradiolActive
Code: 4TI98Z838EClass: ACTIBQuantity: 1 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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