Orange Book product · Generic (ANDA)
AMLODIPINE AND OLMESARTAN MEDOXOMIL
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
At a glance
Oct 28, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Strength
EQ 5MG BASE;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 207216
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
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ANDA 209600 · ACCORD HLTHCARE INC
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ANDA 207435 · MICRO LABS
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ANDA 207771 · ZYDUS PHARMS
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ANDA 209042 · ALKEM LABS LTD
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ANDA 207073 · ALEMBIC
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ANDA 207807 · GLENMARK PHARMS LTD
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ANDA 206906 · AUROBINDO PHARMA
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ANDA 207450 · JUBILANT GENERICS
- 2016AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 202933 · TORRENT
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.
