FDA — authorised 30 June 1971
- Marketing authorisation holder: TRIAX PHARMS
- Status: approved
🇺🇸 Minocycline Hydrochloride in United States
FDA authorised Minocycline Hydrochloride on 30 June 1971
Marketing authorisations
FDA — authorised 10 August 1982
- Application: NDA050451
- Marketing authorisation holder: TRIAX PHARMS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA063181
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA063065
- Marketing authorisation holder: WATSON LABS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 March 1992
- Application: ANDA063011
- Marketing authorisation holder: ZYDUS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 March 1992
- Application: ANDA063009
- Marketing authorisation holder: ZYDUS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 March 1999
- Application: ANDA065005
- Marketing authorisation holder: IMPAX LABS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 November 2000
- Application: ANDA065062
- Marketing authorisation holder: TORRENT
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 2002
- Application: NDA050781
- Marketing authorisation holder: ORAPHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 April 2003
- Application: ANDA065131
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 January 2004
- Application: ANDA065156
- Marketing authorisation holder: TORRENT
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2007
- Application: ANDA065436
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2009
- Application: ANDA090024
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 July 2010
- Application: ANDA090911
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 November 2011
- Application: ANDA091424
- Marketing authorisation holder: LUPIN
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 July 2012
- Application: NDA201922
- Marketing authorisation holder: JOURNEY
- Local brand name: XIMINO
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 November 2012
- Application: ANDA202261
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 May 2013
- Application: ANDA090867
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 August 2014
- Application: ANDA203443
- Marketing authorisation holder: RISING
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 September 2014
- Application: ANDA091118
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 December 2015
- Application: ANDA204394
- Marketing authorisation holder: SUN PHARM
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 January 2016
- Application: ANDA090217
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA204453
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA203553
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 May 2020
- Application: ANDA213662
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2022
- Application: ANDA215466
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 2024
- Application: NDA213690
- Marketing authorisation holder: JOURNEY
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Minocycline Hydrochloride for manufacturing (CMC) purposes on 20 February 2024. This approval was granted to JOURNEY, the marketing authorisation holder. The application number for this approval is NDA213690.
FDA — authorised 1 November 2024
- Application: NDA219015
- Marketing authorisation holder: JOURNEY
- Local brand name: EMROSI
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Minocycline Hydrochloride, a new formulation or new manufacturer, for marketing by JOURNEY on 1 November 2024. This approval was granted under the standard expedited pathway, with application number NDA219015. The approval allows JOURNEY to market Minocycline Hydrochloride in the United States.
FDA
- Application: ANDA214934
- Marketing authorisation holder: NEXUS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Minocycline Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Minocycline Hydrochloride approved in United States?
Yes. FDA authorised it on 30 June 1971; FDA authorised it on 10 August 1982; FDA authorised it on 30 December 1991.
Who is the marketing authorisation holder for Minocycline Hydrochloride in United States?
TRIAX PHARMS holds the US marketing authorisation.