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FDA ANDA · ANDA208727
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA208727
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-15
LATEST ACTION
2023-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 40MG · TABLET · ORAL
Approval history
2023-08-25Labeling · Supplement 13 · standardAP
2023-08-25Labeling · Supplement 11 · standardAP
2020-04-13Labeling · Supplement 4 · standardAP
2016-12-15UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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