Orange Book product · Brand (NDA)
RITALIN LA
METHYLPHENIDATE HYDROCHLORIDE
At a glance
Jun 05, 2002
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 05, 2002
24 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE HYDROCHLORIDE
Strength
40MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
NDA 021284
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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
- 2020METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 207414 · CHARTWELL MOLECULAR
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.
