FDA — authorised 19 November 1953
- Application: NDA050273
- Marketing authorisation holder: LEDERLE
- Local brand name: ACHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TETRACYCLINE HYDROCHLORIDE in United States
FDA authorised TETRACYCLINE HYDROCHLORIDE on 19 November 1953
Marketing authorisations
FDA — authorised 17 September 1954
- Application: ANDA060429
- Marketing authorisation holder: APOTHECON
- Local brand name: SUMYCIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 1954
- Application: ANDA060347
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: PANMYCIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 January 1955
- Application: NDA050263
- Marketing authorisation holder: LEDERLE
- Local brand name: ACHROMYCIN V
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 November 1955
- Application: NDA050268
- Marketing authorisation holder: STORZ
- Local brand name: ACHROMYCIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 April 1957
- Application: NDA050266
- Marketing authorisation holder: STORZ
- Local brand name: ACHROMYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 21 June 1957
- Application: ANDA060400
- Marketing authorisation holder: PH HEALTH
- Local brand name: SUMYCIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 October 1957
- Application: NDA050278
- Marketing authorisation holder: AVET
- Local brand name: ACHROMYCIN V
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 July 1963
- Application: ANDA060704
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 October 1964
- Application: ANDA060174
- Marketing authorisation holder: FERRANTE
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 November 1964
- Application: ANDA060173
- Marketing authorisation holder: FERRANTE
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 1968
- Application: ANDA060783
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 February 1971
- Application: ANDA061147
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: SUMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1971
- Application: ANDA060469
- Marketing authorisation holder: IMPAX LABS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 May 1972
- Application: ANDA061214
- Marketing authorisation holder: ROXANE
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1972
- Application: ANDA061658
- Marketing authorisation holder: BRISTOL
- Local brand name: BRISTACYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 December 1974
- Application: ANDA061888
- Marketing authorisation holder: BRISTOL
- Local brand name: BRISTACYCLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 1977
- Application: ANDA062085
- Marketing authorisation holder: MAST MM
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 November 1977
- Application: ANDA060768
- Marketing authorisation holder: HIKMA
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 May 1978
- Application: ANDA062103
- Marketing authorisation holder: WATSON LABS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 1978
- Application: ANDA062175
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CYCLOPAR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 February 1980
- Application: ANDA060736
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 October 1981
- Application: ANDA062343
- Marketing authorisation holder: WATSON LABS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 March 1985
- Application: ANDA062540
- Marketing authorisation holder: SUPERPHARM
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 August 1988
- Application: ANDA062752
- Marketing authorisation holder: CHARTWELL TETRA
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 September 1988
- Application: ANDA061471
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 March 1994
- Application: NDA050653
- Marketing authorisation holder: SCHIFF AND CO
- Local brand name: ACTISITE
- Indication: FIBER, EXTENDED RELEASE — PERIODONTAL
- Status: approved
FDA — authorised 18 September 2018
- Application: ANDA210674
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 November 2018
- Application: ANDA210662
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 March 2020
- Application: ANDA212635
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 2023
- Application: ANDA205770
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
FDA
- Application: ANDA060446
- Marketing authorisation holder: PROTER
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA061443
- Marketing authorisation holder: SOLVAY
- Local brand name: RETET
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062332
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CYCLOPAR
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA061468
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: TETRAMED
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA061705
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: PANMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA060343
- Marketing authorisation holder: ANGUS
- Local brand name: TETRACHEL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA061148
- Marketing authorisation holder: HEATHER
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060291
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062300
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062686
- Marketing authorisation holder: PVT FORM
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA061685
- Marketing authorisation holder: WYETH AYERST
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060633
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA060290
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060471
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
TETRACYCLINE 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 TETRACYCLINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 19 November 1953; FDA authorised it on 17 September 1954; FDA authorised it on 28 September 1954.
Who is the marketing authorisation holder for TETRACYCLINE HYDROCHLORIDE in United States?
LEDERLE holds the US marketing authorisation.