FDA — authorised 9 March 1988
- Application: ANDA062569
- Marketing authorisation holder: HIKMA
- Local brand name: DOXYCYCLINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 duration of the antibiotic therapy in United States
FDA authorised duration of the antibiotic therapy on 9 March 1988
Marketing authorisations
FDA — authorised 28 April 2000
- Application: ANDA065041
- Marketing authorisation holder: WATSON LABS
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 2000
- Application: ANDA065032
- Marketing authorisation holder: SANDOZ INC
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 November 2000
- Application: ANDA065053
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 2000
- Application: ANDA065055
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 December 2000
- Application: ANDA065070
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DOXYCYCLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2005
- Application: ANDA065285
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: DOXYCYCLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2006
- Application: ANDA065356
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: DOXYCYCLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2006
- Application: ANDA065353
- Marketing authorisation holder: SANDOZ INC
- Local brand name: DOXYCYCLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 2011
- Application: ANDA200065
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 December 2011
- Application: ANDA091605
- Marketing authorisation holder: HERITAGE
- Local brand name: DOXYCYCLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2013
- Application: ANDA201678
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DOXYCYCLINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 May 2015
- Application: ANDA204446
- Marketing authorisation holder: COSETTE
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2016
- Application: ANDA205115
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA209396
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 January 2021
- Application: ANDA208942
- Marketing authorisation holder: RISING
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 2025
- Application: ANDA210381
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2025
- Application: ANDA219978
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA091277
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA208286
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ZENAVOD
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA090855
- Marketing authorisation holder: MYLAN
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA203278
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: DOXYCYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
duration of the antibiotic therapy 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 duration of the antibiotic therapy approved in United States?
Yes. FDA authorised it on 9 March 1988; FDA authorised it on 28 April 2000; FDA authorised it on 30 June 2000.
Who is the marketing authorisation holder for duration of the antibiotic therapy in United States?
HIKMA holds the US marketing authorisation.