← FDA Drug Approvals (Drugs@FDA)
ACETYLCYSTEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2022-02-23
Drug application
- FDA Application #
ANDA215620
- 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
- REGCON HOLDINGS
- Manufacturer
- Indoco Remedies Limited
- First approval
- 2022-02-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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