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FDA Approval

Mondoxyne

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

FDA Approval Summary

Company
Effective Date
September 2, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Doxycycline(50 mg in 50 mg)

Products1

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

Mondoxyne

Product Details

NDC Product Code
69668-431
Application Number
ANDA204446
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 2, 2015
Code: N12000U13OClass: ACTIMQuantity: 50 mg in 50 mg
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