← FDA Drug Approvals (Drugs@FDA)
RESTORIL
NDA · New Drug Application · Sponsor: SPECGX LLC · Approved 1981-02-27
Drug application
- FDA Application #
NDA018163- Application type
- New Drug Application
- Brand name
- RESTORIL
- Generic name
- TEMAZEPAM
- Active ingredients
- TEMAZEPAM
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 1981-02-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown