Orange Book product · Brand (NDA)
METHADOSE
METHADONE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHADONE HYDROCHLORIDE
Strength
10MG/ML
Dosage form
CONCENTRATE
Route
ORAL
TE code
AA
Application
NDA 017116
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 021624 · MYLAN INSTITUTIONAL
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 006383 · MALLINCKRODT INC
- —DOLOPHINE HYDROCHLORIDEBrand (NDA)
NDA 006134 · HIKMA
- —WESTADONEBrand (NDA)
NDA 017108 · SANDOZ
- —METHADONE HYDROCHLORIDEBrand (NDA)
NDA 017058 · HIKMA
- 2025METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218609 · HIKMA
- 2024METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218252 · BRECKENRIDGE
- 2021METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212094 · LANNETT CO INC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212093 · LANNETT CO INC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 090635 · THEPHARMANETWORK LLC
- 2020METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204166 · VISTAPHARM LLC
- 2019METHADONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207537 · SPECGX LLC
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.
