Orange Book product · Generic (ANDA)
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE
At a glance
Aug 31, 2020
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MEMANTINE HYDROCHLORIDE
Strength
2MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 210319
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MEMANTINE HYDROCHLORIDE
- 2010NAMENDA XRBrand (NDA)
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NDA 021487 · ABBVIE
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ANDA 206310 · MACLEODS PHARMS LTD
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ANDA 214651 · AUROBINDO PHARMA LTD
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ANDA 211100 · YICHANG HUMANWELL
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ANDA 210587 · PURACAP LABS BLU
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ANDA 212947 · YILING
- 2020MEMANTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205365 · ANI PHARMS
- 2020MEMANTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208173 · HIKMA
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.
