FDA — authorised 29 January 1964
- Application: ANDA060869
- Marketing authorisation holder: PROTER
- Local brand name: OXYTETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 OXYTETRACYCLINE HYDROCHLORIDE in United States
FDA authorised OXYTETRACYCLINE HYDROCHLORIDE on 29 January 1964
Marketing authorisations
FDA — authorised 8 September 1964
- Application: NDA050286
- Marketing authorisation holder: PFIZER
- Local brand name: TERRAMYCIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 August 1967
- Application: ANDA060760
- Marketing authorisation holder: IMPAX LABS
- Local brand name: OXYTETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 August 1967
- Application: ANDA060179
- Marketing authorisation holder: FERRANTE
- Local brand name: OXY-KESSO-TETRA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 1967
- Application: ANDA060770
- Marketing authorisation holder: HIKMA
- Local brand name: OXYTETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA061009
- Marketing authorisation holder: PFIZER
- Local brand name: TERRAMYCIN-POLYMYXIN
- Indication: TABLET — VAGINAL
- Status: approved
FDA
- Application: ANDA060634
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: OXYTETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060586
- Marketing authorisation holder: PFIZER
- Local brand name: TERRAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
OXYTETRACYCLINE 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 OXYTETRACYCLINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 29 January 1964; FDA authorised it on 8 September 1964; FDA authorised it on 9 August 1967.
Who is the marketing authorisation holder for OXYTETRACYCLINE HYDROCHLORIDE in United States?
PROTER holds the US marketing authorisation.