← FDA Drug Approvals (Drugs@FDA)
TRAMADOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-01-31
Drug application
- FDA Application #
ANDA209404- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TRAMADOL HYDROCHLORIDE
- Generic name
- TRAMADOL HYDROCHLORIDE
- Active ingredients
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MACLEODS PHARMS LTD
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2025-01-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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