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Clomiphene Citrate

Clomiphene Citrate Tablets

Approved
Approval ID

7d91b06a-df0d-56c3-e053-2991aa0a4180

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 17, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-4676
Application NumberANDA075528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clomiphene Citrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2021
FDA Product Classification

INGREDIENTS (5)

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

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Clomiphene Citrate - FDA Drug Approval Details