Orange Book product · Generic (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE
At a glance
Sep 25, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 209468
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
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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
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ANDA 208756 · RHODES PHARMS
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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.
