FDA — authorised 19 July 1950
- Application: NDA007392
- Marketing authorisation holder: LILLY
- Local brand name: SECONAL SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 SECOBARBITAL SODIUM in United States
FDA authorised SECOBARBITAL SODIUM on 19 July 1950 · 18 US adverse-event reports
Marketing authorisations
FDA — authorised 7 April 1975
- Application: ANDA084225
- Marketing authorisation holder: BARR
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 December 1976
- Application: ANDA085285
- Marketing authorisation holder: KV PHARM
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1978
- Application: ANDA085798
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1978
- Application: ANDA085903
- Marketing authorisation holder: LANNETT
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 June 1978
- Application: ANDA085909
- Marketing authorisation holder: LANNETT
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 October 1978
- Application: ANDA085895
- Marketing authorisation holder: EVERYLIFE
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 1981
- Application: ANDA085477
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 October 1983
- Application: ANDA086101
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: SECONAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA084762
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA086390
- Marketing authorisation holder: WYETH AYERST
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA085898
- Marketing authorisation holder: VITARINE
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA086530
- Marketing authorisation holder: LILLY
- Local brand name: SECONAL SODIUM
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA085792
- Marketing authorisation holder: WATSON LABS
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA084676
- Marketing authorisation holder: HALSEY
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA084561
- Marketing authorisation holder: PERRIGO
- Local brand name: SECOBARBITAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 18
Most-reported reactions
- Drug Abuse — 5 reports (27.78%)
- Cardiac Arrest — 2 reports (11.11%)
- Convulsion — 2 reports (11.11%)
- Drug Dependence — 2 reports (11.11%)
- Respiratory Arrest — 2 reports (11.11%)
- Abdominal Pain Upper — 1 report (5.56%)
- Accidental Death — 1 report (5.56%)
- Accidental Overdose — 1 report (5.56%)
- Acute Psychosis — 1 report (5.56%)
- Acute Respiratory Failure — 1 report (5.56%)
SECOBARBITAL SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SECOBARBITAL SODIUM approved in United States?
Yes. FDA authorised it on 19 July 1950; FDA authorised it on 7 April 1975; FDA authorised it on 2 December 1976.
Who is the marketing authorisation holder for SECOBARBITAL SODIUM in United States?
LILLY holds the US marketing authorisation.