FDA — authorised 5 March 1973
- Application: BLA017067
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Chorionic Gonadotropin in United States
FDA authorised Chorionic Gonadotropin on 5 March 1973 · 529 US adverse-event reports
Marketing authorisations
FDA — authorised 15 January 1974
- Application: BLA017016
- Marketing authorisation holder: FERRING
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089313
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089315
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089316
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089314
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089312
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CHORIONIC GONADOTROPIN
- Indication: Injectable — Injection
- 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: 22 April 2025 – 22 April 2026
- Total reports: 529
Most-reported reactions
- Ovarian Hyperstimulation Syndrome — 170 reports (32.14%)
- Off Label Use — 52 reports (9.83%)
- Drug Ineffective — 49 reports (9.26%)
- Drug Exposure During Pregnancy — 47 reports (8.88%)
- Abortion Spontaneous — 41 reports (7.75%)
- Ascites — 37 reports (6.99%)
- Ectopic Pregnancy — 36 reports (6.81%)
- Nausea — 35 reports (6.62%)
- Abdominal Distension — 32 reports (6.05%)
- Caesarean Section — 30 reports (5.67%)
Other Reproductive/Fertility approved in United States
Frequently asked questions
Is Chorionic Gonadotropin approved in United States?
Yes. FDA authorised it on 5 March 1973; FDA authorised it on 15 January 1974; FDA has authorised it.
Who is the marketing authorisation holder for Chorionic Gonadotropin in United States?
FRESENIUS KABI USA holds the US marketing authorisation.