FDA — authorised 30 December 1991
- Application: ANDA063065
- Marketing authorisation holder: WATSON LABS
- Local brand name: MINOCYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 MINOCYCLINE HYDROCHLORIDE in United States
FDA authorised MINOCYCLINE HYDROCHLORIDE on 30 December 1991 · 8,258 US adverse-event reports
Marketing authorisations
FDA — authorised 2 March 1992
- Application: ANDA063009
- Marketing authorisation holder: ZYDUS
- 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 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 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 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 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
- 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: 8,258
Most-reported reactions
- Drug Ineffective — 1,174 reports (14.22%)
- Off Label Use — 1,075 reports (13.02%)
- Drug Intolerance — 897 reports (10.86%)
- Rheumatoid Arthritis — 831 reports (10.06%)
- Pain — 809 reports (9.8%)
- Nausea — 728 reports (8.82%)
- Drug Hypersensitivity — 702 reports (8.5%)
- Arthralgia — 697 reports (8.44%)
- Rash — 674 reports (8.16%)
- Joint Swelling — 671 reports (8.13%)
MINOCYCLINE 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 MINOCYCLINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 December 1991; FDA authorised it on 2 March 1992; FDA authorised it on 2 March 1992.
Who is the marketing authorisation holder for MINOCYCLINE HYDROCHLORIDE in United States?
WATSON LABS holds the US marketing authorisation.