FDA — authorised 16 April 1991
- Application: ANDA063180
- Marketing authorisation holder: SLAYBACK
- Local brand name: LINCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 LINCOMYCIN HYDROCHLORIDE in United States
FDA authorised LINCOMYCIN HYDROCHLORIDE on 16 April 1991 · 41 US adverse-event reports
Marketing authorisations
FDA — authorised 4 June 2015
- Application: ANDA201746
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: LINCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 March 2021
- Application: ANDA212770
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: LINCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 September 2022
- Application: ANDA215657
- Marketing authorisation holder: GLAND
- Local brand name: LINCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2022
- Application: ANDA216662
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: LINCOMYCIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA062784
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: LINCOMYCIN HCL
- 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: 20 April 2025 – 20 April 2026
- Total reports: 41
Most-reported reactions
- Drug Hypersensitivity — 11 reports (26.83%)
- Drug Ineffective — 5 reports (12.2%)
- Asthenia — 4 reports (9.76%)
- Rash — 4 reports (9.76%)
- Condition Aggravated — 3 reports (7.32%)
- Diarrhoea — 3 reports (7.32%)
- Erythema — 3 reports (7.32%)
- Gastrointestinal Disorder — 3 reports (7.32%)
- Pyrexia — 3 reports (7.32%)
- Aspartate Aminotransferase Increased — 2 reports (4.88%)
LINCOMYCIN HYDROCHLORIDE 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 LINCOMYCIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 16 April 1991; FDA authorised it on 4 June 2015; FDA authorised it on 12 March 2021.
Who is the marketing authorisation holder for LINCOMYCIN HYDROCHLORIDE in United States?
SLAYBACK holds the US marketing authorisation.