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DIPHENHYDRAMINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 1982-02-10

Drug application

FDA Application #
ANDA087513
Application type
Abbreviated New Drug Application (Generic)
Brand name
DIPHENHYDRAMINE HYDROCHLORIDE
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
ELIXIR
Route
ORAL
Marketing status
Prescription
Sponsor
PHARM ASSOC
Manufacturer
PAI Holdings, LLC dba PAI Pharma
First approval
1982-02-10

Source

Authoritative
Drugs@FDA application overview
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