Orange Book product · Generic (ANDA)
MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDE
At a glance
May 16, 1995
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 16, 1995
31 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
MEXILETINE HYDROCHLORIDE
Strength
250MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 074377
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of MEXILETINE HYDROCHLORIDE
- 1985MEXITILBrand (NDA)
NDA 018873 · BOEHRINGER INGELHEIM
- 2026MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219987 · MACLEODS PHARMS LTD
- 2023MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215876 · QUAGEN
- 2022MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216463 · ANNORA PHARMA
- 2022MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215315 · RISING
- 2021MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214089 · SENORES PHARMS
- 2021MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214352 · INGENUS PHARMS LLC
- 2020MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213500 · CROSSMEDIKA SA
- 1998MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074865 · WATSON LABS
- 1997MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074711 · WATSON LABS
- 1996MEXILETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074450 · ANI PHARMS
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.
