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HYDROMORPHONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS US · Approved 2015-04-06
Drug application
- FDA Application #
ANDA204278- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROMORPHONE HYDROCHLORIDE
- Generic name
- HYDROMORPHONE HYDROCHLORIDE
- Active ingredients
- HYDROMORPHONE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PADAGIS US
- Manufacturer
- Padagis US LLC
- First approval
- 2015-04-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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