← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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