← FDA Drug Approvals (Drugs@FDA)

AMLODIPINE BESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PURACAP LABS BLU · Approved 2016-07-11

Drug application

FDA Application #
ANDA207821
Application type
Abbreviated New Drug Application (Generic)
Brand name
AMLODIPINE BESYLATE
Generic name
AMLODIPINE BESYLATE
Active ingredients
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
PURACAP LABS BLU
Manufacturer
POLYGEN PHARMACEUTICALS INC.
First approval
2016-07-11

Source

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