Orange Book product · Generic (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE
At a glance
Oct 09, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Strength
5MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 210279
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 208756 · RHODES PHARMS
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ANDA 209468 · LANNETT CO INC
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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.
