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Depo-Estradiol

DEPO-ESTRADIOL Estradiol cypionate injection, USP

Approved
Approval ID

4165ef14-8dfc-4165-859c-dcf06174d69c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 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.

estradiol cypionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-1729
Application NumberANDA085470
Product Classification
M
Marketing Category
C73584
G
Generic Name
estradiol cypionate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 3, 2011
FDA Product Classification

INGREDIENTS (2)

ESTRADIOL CYPIONATEActive
Quantity: 5 mg in 1 mL
Code: 7E1DV054LO
Classification: ACTIB
COTTONSEED OILInactive
Quantity: 913 mg in 1 mL
Code: H3E878020N
Classification: IACT

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Depo-Estradiol - FDA Drug Approval Details