← FDA Drug Approvals (Drugs@FDA)

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: STRIDES PHARMA INTL · Approved 2015-06-01

Drug application

FDA Application #
ANDA201087
Application type
Abbreviated New Drug Application (Generic)
Brand name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Generic name
AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE
Active ingredients
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
STRIDES PHARMA INTL
Manufacturer
Strides Pharma Science Limited
First approval
2015-06-01

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown