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FDA Approval

Clomiphene Citrate

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

FDA Approval Summary

Company
Effective Date
September 23, 2010
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.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products1

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

Clomiphene Citrate

Product Details

NDC Product Code
21695-114
Application Number
ANDA075528
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 17, 2009
ClomifeneActive
Code: 1B8447E7YIClass: ACTIBQuantity: 50 mg in 1 1
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Clomiphene Citrate - FDA Approval | MedPath