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Clomiphene Citrate

Clomiphene Citrate Tablets

Approved
Approval ID

6370e342-16a5-4339-a13f-ba275fd5de09

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Clomiphene Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63629-2165
Application NumberANDA075528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clomiphene Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (5)

CLOMIPHENE CITRATEActive
Quantity: 50 mg in 1 1
Code: 1B8447E7YI
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

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Clomiphene Citrate - FDA Drug Approval Details