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FDA Approval

CLOMID

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

FDA Approval Summary

Company
Effective Date
May 31, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clomifene(50 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

CLOMID

Product Details

NDC Product Code
50090-6500
Application Number
ANDA075528
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 23, 2022
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ClomifeneActive
Code: 1B8447E7YIClass: ACTIBQuantity: 50 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
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