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CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMS INC · Approved 1986-12-10

Drug application

FDA Application #
ANDA071297
Application type
Abbreviated New Drug Application (Generic)
Brand name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Generic name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Active ingredients
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
MYLAN PHARMS INC
Manufacturer
Mylan Pharmaceuticals Inc.
First approval
1986-12-10

Source

Authoritative
Drugs@FDA application overview
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