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Progesterone

PROGESTERONE INJECTION, USP IN SESAME OIL - FOR INTRAMUSCULAR USE ONLYRx only

Approved
Approval ID

83cfc12e-75d1-4284-bcc3-beadcbd27171

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 14, 2018

Manufacturers
FDA

West-Ward Pharmaceuticals Corp

DUNS: 001230762

Products 1

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

Progesterone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9725
Application NumberANDA091033
Product Classification
M
Marketing Category
C73584
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 17, 2018
FDA Product Classification

INGREDIENTS (3)

PROGESTERONEActive
Quantity: 50 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT

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Progesterone - FDA Drug Approval Details