FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Summary
FDA approved FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) by SANDOZ. NDA (New Drug) approval (Labeling) on 2023-10-13. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA021278-31
Action Date
2023-10-13
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
FOCALIN (generic: DEXMETHYLPHENIDATE HYDROCHLORIDE), TABLET, ORAL. Application: NDA021278
Company
Context & Analysis
SANDOZ has 75 FDA actions in our database.
Frequently Asked Questions
How often does SANDOZ have FDA actions?
SANDOZ has 75 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 "NDA021278-31" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22