← FDA Drug Approvals (Drugs@FDA)
ACETYLCYSTEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SAGENT PHARMS INC · Approved 2017-10-31
Drug application
- FDA Application #
ANDA091684
- 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
- SAGENT PHARMS INC
- Manufacturer
- Sagent Pharmaceuticals
- First approval
- 2017-10-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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