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CYCLOBENZAPRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2007-02-28
Drug application
- FDA Application #
ANDA077797- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Generic name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active ingredients
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PRINSTON INC
- Manufacturer
- Solco Healthcare U.S., LLC
- First approval
- 2007-02-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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