← FDA Drug Approvals (Drugs@FDA)

FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CADILA PHARMS LTD · Approved 2019-05-23

Drug application

FDA Application #
ANDA206993
Application type
Abbreviated New Drug Application (Generic)
Brand name
FLUOXETINE HYDROCHLORIDE
Generic name
FLUOXETINE
Active ingredients
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
CADILA PHARMS LTD
Manufacturer
Cadila Pharmaceuticals Limited
First approval
2019-05-23

Source

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