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DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2017-12-06

Drug application

FDA Application #
ANDA208518
Application type
Abbreviated New Drug Application (Generic)
Brand name
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Generic name
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MG
Active ingredients
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
PH HEALTH
Manufacturer
Endo USA, Inc.
First approval
2017-12-06

Source

Authoritative
Drugs@FDA application overview
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