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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
May 18, 2018
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.

Clomiphene Citrate

Product Details

NDC Product Code
50090-0677
Application Number
NDA016131
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
March 5, 2018
ClomifeneActive
Code: 1B8447E7YIClass: ACTIBQuantity: 50 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
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