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ACETYLCYSTEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2023-04-19

Drug application

FDA Application #
ANDA217182
Application type
Abbreviated New Drug Application (Generic)
Brand name
ACETYLCYSTEINE
Generic name
ACETYLCYSTEINE
Active ingredients
ACETYLCYSTEINE
Dosage form
INJECTABLE
Route
INTRAVENOUS
Marketing status
Prescription
Sponsor
ONESOURCE SPECIALTY
Manufacturer
Hikma Pharmaceuticals USA Inc.
First approval
2023-04-19

Source

Authoritative
Drugs@FDA application overview
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