Orange Book product · Generic (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE
At a glance
Sep 24, 2015
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 201231
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXMETHYLPHENIDATE HYDROCHLORIDE
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ANDA 209754 · BIONPHARMA
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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
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.
