HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Summary
FDA approved HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE by NOVEL LABS INC. ANDA (Generic) approval (Labeling) on 2025-08-01. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA091528-6
Action Date
2025-08-01
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, TABLET, ORAL. Application: ANDA091528
Company
Context & Analysis
NOVEL LABS INC has 13 FDA actions in our database.
Frequently Asked Questions
How often does NOVEL LABS INC have FDA actions?
NOVEL LABS INC has 13 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA091528-6" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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