Orange Book product · Brand (NDA)
ANTIVERT
MECLIZINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MECLIZINE HYDROCHLORIDE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 010721
Product number
005
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.
- 2022MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203003 · CHARTWELL RX
- 2022MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200791 · INVAGEN PHARMS
- 2022MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200432 · INVAGEN PHARMS
- 2020MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213957 · ZYDUS LIFESCIENCES
- 2019MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205136 · HERITAGE
- 2012MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202640 · AUROBINDO PHARMA USA
- 2012MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200294 · EPIC PHARMA LLC
- 2011MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201451 · AMNEAL PHARMS
- 2010MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040659 · JUBILANT CADISTA
- 1997MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040179 · RISING
- 1989MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 084843 · SANDOZ
- 1989MECLIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 084092 · SCIEGEN 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.
