Treats infections caused by susceptible strains of the designated organisms in the…. Sold as Achromycin V, Achromycin, Topicycline, Actisite. Every FDA application for this active ingredient: 7 branded and 46 generic.
As of Nov 15, 2026, FDA lists 53 applications for Tetracycline Hydrochloride (sold as Achromycin V, Achromycin, Topicycline and others), first approved Nov 19, 1953, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Tetracycline HCl | Part D | $6.5M | +34% | 71,206 |
| Nov 19, 1953 | AchromycinNDA 50273 | Lederle | 26 | Discontinued |
| Sep 17, 1954 | SumycinANDA 60429 | Apothecon | 11 | Discontinued |
| Sep 28, 1954 | PanmycinANDA 60347 | Pharmacia And Upjohn | 6 | Discontinued |
| Jan 27, 1955 | Achromycin VNDA 50263 | Lederle | 57 | Discontinued |
| Sep 2, 1955 | TetracynANDA 60095 | Pfipharmecs | 0 | Discontinued |
| Nov 23, 1955 | AchromycinNDA 50268 | Storz | 29 | Discontinued |
| Apr 19, 1957 | AchromycinNDA 50266 | Storz | 2 | Discontinued |
| Jun 21, 1957 | SumycinANDA 60400 | Ph Health | 4 | Discontinued |
| Oct 8, 1957 | Achromycin VNDA 50278 | Avet | 21 | Marketed |
| Jul 5, 1963 | Tetracycline HydrochlorideANDA 60704 | Ivax Sub Teva Pharms | 28 | Discontinued |
| Oct 22, 1964 | Tetracycline HydrochlorideANDA 60174 | Ferrante | 0 | Discontinued |
| Nov 19, 1964 | Tetracycline HydrochlorideANDA 60173 | Ferrante | 0 | Discontinued |
| Jul 17, 1968 | Tetracycline HydrochlorideANDA 60783 | Aurobindo Pharma USA | 11 | Discontinued |
| Feb 10, 1971 | SumycinANDA 61147 | Strides Pharma Intl | 9 | Marketed |
| Jul 13, 1971 | Tetracycline HydrochlorideANDA 60469 | Impax Labs | 8 | Discontinued |
| May 22, 1972 | Tetracycline HydrochlorideANDA 61214 | Roxane | 0 | Discontinued |
| Jun 28, 1972 | BristacyclineANDA 61658 | Bristol | 0 | Discontinued |
| Jun 8, 1973 | CycloparANDA 61725 | Warner Chilcott | 0 | Discontinued |
| Dec 5, 1974 | BristacyclineANDA 61888 | Bristol | 0 | Discontinued |
| Dec 24, 1974 | Tetracycline HydrochlorideANDA 61837 | Watson Labs | 20 | Marketed |
| Sep 2, 1977 | Tetracycline HydrochlorideANDA 62085 | Mast Mm | 0 | Discontinued |
| Sep 21, 1977 | TopicyclineNDA 50493 · New dosage form | Shire | 28 | Discontinued |
| Nov 7, 1977 | Tetracycline HydrochlorideANDA 60768 | Hikma | 2 | Discontinued |
| May 8, 1978 | Tetracycline HydrochlorideANDA 62103 | Watson Labs | 0 | Discontinued |
| Aug 29, 1978 | CycloparANDA 62175 | Warner Chilcott | 0 | Discontinued |
| Feb 7, 1980 | Tetracycline HydrochlorideANDA 60736 | Sun Pharm Industries | 11 | Discontinued |
| Oct 2, 1981 | Tetracycline HydrochlorideANDA 62343 | Watson Labs | 10 | Discontinued |
| Mar 21, 1985 | Tetracycline HydrochlorideANDA 62540 | Superpharm | 0 | Discontinued |
| Aug 12, 1988 | Tetracycline HydrochlorideANDA 62752 | Chartwell Tetra | 2 | Marketed |
| Mar 25, 1994 | ActisiteNDA 50653 · New dosage form | Schiff And Co | 1 | Discontinued |
| Sep 16, 1994 | Tetracycline HydrochlorideANDA 61471 | Ani Pharms | 5 | Discontinued |
| Sep 18, 2018 | Tetracycline HydrochlorideANDA 210674 | Amneal Pharms Ny | 0 | Marketed |
| Nov 7, 2018 | Tetracycline HydrochlorideANDA 210662 | Breckenridge | 0 | Marketed |
| Mar 3, 2020 | Tetracycline HydrochlorideANDA 212635 | Novitium Pharma | 0 | Marketed |
| — | Tetracycline HydrochlorideANDA 60471 | Valeant Pharm Intl | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 60059 | Elkins Sinn | 0 | Discontinued |
| — | TetracynANDA 60082 | Pfipharmecs | 0 | Discontinued |
| — | TetracynANDA 60096 | Pfizer | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 60290 | Purepac Pharm | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 60291 | Purepac Pharm | 0 | Discontinued |
| — | TetrachelANDA 60343 | Angus | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 60446 | Proter | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 60633 | Alpharma US Pharms | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 61148 | Heather | 0 | Discontinued |
| — | RetetANDA 61443 | Solvay | 0 | Discontinued |
| — | TetramedANDA 61468 | Ivax Sub Teva Pharms | 0 | Discontinued |
| — | RobitetANDA 61734 | Wyeth Ayerst | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 61685 | Wyeth Ayerst | 0 | Discontinued |
| — | PanmycinANDA 61705 | Pharmacia And Upjohn | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 61802 | Abbott | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 62300 | Warner Chilcott | 0 | Discontinued |
| — | CycloparANDA 62332 | Warner Chilcott | 0 | Discontinued |
| — | Tetracycline HydrochlorideANDA 62686 | Pvt Form | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Apothecon
Aurobindo Pharma USA
Strides Pharma Intl
Impax Labs
Roxane
Hikma
Sun Pharm Industries
Novitium Pharma
Pfizer
Abbott