Orange Book product · Brand (NDA)
FOCALIN XR
DEXMETHYLPHENIDATE HYDROCHLORIDE
At a glance
Aug 11, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 2010
16 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Strength
40MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021802
Product number
006
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2001FOCALINBrand (NDA)
NDA 021278 · SANDOZ
- 2021DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 215523 · ASCENT PHARMS INC
- 2021DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 078992 · PLATINUM
- 2021DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 206734 · SUN PHARM INDS INC
- 2020DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 213813 · GRANULES
- 2020DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 209754 · BIONPHARMA
- 2019DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 212631 · ALKEM LABS LTD
- 2018DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 210279 · ADARE PHARMS INC
- 2018DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 209211 · CEDIPROF INC
- 2017DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 208756 · RHODES PHARMS
- 2017DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 209468 · LANNETT CO INC
- 2017DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 203614 · IMPAX LABS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
