Orange Book product · Generic (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE
At a glance
Nov 05, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Strength
5MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 206734
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXMETHYLPHENIDATE HYDROCHLORIDE
- 2005FOCALIN XRBrand (NDA)
NDA 021802 · SANDOZ
- 2001FOCALINBrand (NDA)
NDA 021278 · SANDOZ
- 2021DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 215523 · ASCENT PHARMS INC
- 2021DEXMETHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 078992 · PLATINUM
- 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.
