Fluocinolone Acetonide

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

FDA Approval Summary

Company

Lupin Pharmaceuticals,Inc.

DUNS: 089153071

Effective Date

February 21, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluocinolone acetonide(0.1 mg in 1 mL)

Registrants1

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

Lupin Inc.

DUNS Number

080038238

Manufacturing Establishments1

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

Novel Laboratories, Inc.

Labeler

Lupin Pharmaceuticals,Inc.

Registrant

Lupin Inc.

DUNS Number

793518643

Products1

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