← FDA Drug Approvals (Drugs@FDA)
ROPIVACAINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANTHEA PHARMA · Approved 2025-03-21
Drug application
- FDA Application #
ANDA219883
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ROPIVACAINE HYDROCHLORIDE
- Generic name
- ROPIVACAINE HYDROCHLORIDE
- Active ingredients
- ROPIVACAINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- ANTHEA PHARMA
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- First approval
- 2025-03-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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