← FDA Drug Approvals (Drugs@FDA)

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2026-01-21

Drug application

FDA Application #
ANDA217922
Application type
Abbreviated New Drug Application (Generic)
Brand name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Active ingredients
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
Aurobindo Pharma Limited
First approval
2026-01-21

Source

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