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FDA Approval

Zovia 1/35

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

FDA Approval Summary

Company
Effective Date
January 24, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Novast Laboratories, Ltd.

527695995

Manufacturing Establishments1

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

Novast Laboratories, Ltd.

Dr. Reddy’s Laboratories Inc.

Novast Laboratories, Ltd.

527695995

Products1

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

Zovia 1/35

Product Details

NDC Product Code
75907-087
Application Number
ANDA209548
Marketing Category
ANDA (C73584)
Effective Date
November 29, 2023
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