Orange Book product · Generic (ANDA)
VALSARTAN AND HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE; VALSARTAN
At a glance
Mar 15, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Strength
12.5MG;80MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 203000
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCHLOROTHIAZIDE; VALSARTAN
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ANDA 201662 · ALEMBIC
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ANDA 203026 · APOTEX INC
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ANDA 202519 · AUROBINDO PHARMA LTD
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ANDA 078946 · LUPIN LTD
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ANDA 091519 · WATSON LABS TEVA
- 2012VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
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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.
