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HYDROMORPHONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: OSMOTICA PHARM US · Approved 2016-07-07
Drug application
- FDA Application #
ANDA205629- 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
- OSMOTICA PHARM US
- Manufacturer
- Trigen Laboratories, LLC
- First approval
- 2016-07-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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