Orange Book product · Generic (ANDA)
METADATE ER
METHYLPHENIDATE HYDROCHLORIDE
At a glance
Oct 20, 1999
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 1999
27 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE HYDROCHLORIDE
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 040306
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHYLPHENIDATE HYDROCHLORIDE
- 2019ADHANSIA XRBrand (NDA)
NDA 212038 · KNOA PHARMA
- 2018JORNAY PMBrand (NDA)
NDA 209311 · IRONSHORE PHARMS
- 2015QUILLICHEW ERBrand (NDA)
NDA 207960 · NEXTWAVE PHARMS
- 2015APTENSIO XRBrand (NDA)
NDA 205831 · RHODES PHARMS
- 2012QUILLIVANT XRBrand (NDA)
NDA 202100 · NEXTWAVE
- 2004RITALIN LABrand (NDA)
NDA 021284 · SANDOZ
- 2003METADATE CDBrand (NDA)
NDA 021259 · AYTU BIOPHARMA
- 2003METHYLINBrand (NDA)
NDA 021475 · SPECGX LLC
- 2002METHYLINBrand (NDA)
NDA 021419 · SPECGX LLC
- 2000CONCERTABrand (NDA)
NDA 021121 · JANSSEN PHARMS
- 2023METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 214447 · ALKEM LABS LTD
- 2021METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 207417 · ASCENT PHARMS 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.
