Active ingredient
Tobramycin
67 finished FDA listings contain Tobramycin as their only active ingredient; 32 combination products also contain it.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- TOBRAMYCIN, TOBRAMYCIN SULFATE
- Dosage forms
- Capsule, Inhalant, Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Ointment, Solution, Solution/ Drops
- Routes
- Intramuscular, Intravenous, Ophthalmic, Oral, Respiratory (Inhalation)
- Manufacturers / labelers
- 46
- Strengths listed
- 1.2 g/30ml · 10 mg/ml · 1200 mg/30ml · 28 mg/1 · 3 mg/g · 3 mg/ml · 300 mg/4ml · 300 mg/5ml · 40 mg/ml
- Brand names in FDA listings
- Bethkis, Kitabis Pak, Tobi, Tobi Podhaler, Tobramycin, Tobramycin Inhalation Solution Pak, Tobrex
Official drug information
Source coverage for Tobramycin:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10627
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 050555
- Sponsor
- NOVARTIS
- Original approval
- 1981-11-25
- Listings
- 1
- Application
- ANDA 062535
- Sponsor
- SANDOZ
- Original approval
- 1984-12-13
- Listings
- 2
- Application
- ANDA 063111
- Sponsor
- HOSPIRA
- Original approval
- 1991-04-30
- Listings
- 1
- Application
- ANDA 064052
- Sponsor
- BAUSCH AND LOMB INC
- Original approval
- 1993-11-29
- Listings
- 8
- Application
- ANDA 064096
- Sponsor
- EPIC PHARMA LLC
- Original approval
- 1996-01-31
- Listings
- 1
- Application
- NDA 050753
- Sponsor
- VIATRIS
- Original approval
- 1997-12-22
- Listings
- 1
- Application
- ANDA 065013
- Sponsor
- XGEN PHARMS
- Original approval
- 2001-08-17
- Listings
- 1
- Application
- ANDA 065122
- Sponsor
- FRESENIUS KABI USA
- Original approval
- 2002-11-29
- Listings
- 2
- Application
- NDA 050789
- Sponsor
- FRESENIUS KABI USA
- Original approval
- 2004-07-13
- Listings
- 2
- Application
- ANDA 065407
- Sponsor
- MYLAN LABS LTD
- Original approval
- 2008-03-11
- Listings
- 2
- Application
- NDA 201820
- Sponsor
- CHIESI
- Original approval
- 2012-10-12
- Listings
- 2
- Application
- NDA 201688
- Sponsor
- VIATRIS
- Original approval
- 2013-03-22
- Listings
- 1
- Application
- ANDA 091589
- Sponsor
- TEVA PHARMS USA
- Original approval
- 2013-10-10
- Listings
- 1
- Application
- ANDA 201422
- Sponsor
- HIKMA
- Original approval
- 2014-05-28
- Listings
- 1
- Application
- NDA 205433
- Sponsor
- PULMOFLOW INC
- Original approval
- 2014-12-02
- Listings
- 2
- Application
- ANDA 205501
- Sponsor
- AMNEAL PHARMS
- Original approval
- 2015-07-13
- Listings
- 1
- Application
- ANDA 206965
- Sponsor
- BAXTER HLTHCARE CORP
- Original approval
- 2016-07-01
- Listings
- 2
- Application
- ANDA 208964
- Sponsor
- LUPIN
- Original approval
- 2017-03-22
- Listings
- 1
- Application
- ANDA 207444
- Sponsor
- SOMERSET THERAPS LLC
- Original approval
- 2017-06-28
- Listings
- 10
- Application
- ANDA 207080
- Sponsor
- DR REDDYS LABS SA
- Original approval
- 2018-07-09
- Listings
- 2
- Application
- ANDA 211847
- Sponsor
- ALEMBIC
- Original approval
- 2019-04-19
- Listings
- 2
- Application
- ANDA 207136
- Sponsor
- SUN PHARM
- Original approval
- 2019-12-26
- Listings
- 2
- Application
- ANDA 210871
- Sponsor
- LUOXIN AUROVITAS
- Original approval
- 2021-01-22
- Listings
- 1
- Application
- ANDA 209346
- Sponsor
- GLAND
- Original approval
- 2021-02-09
- Listings
- 1
- Application
- ANDA 209621
- Sponsor
- GLAND
- Original approval
- 2021-02-11
- Listings
- 2
- Application
- ANDA 212628
- Sponsor
- GLAND
- Original approval
- 2021-03-09
- Listings
- 3
- Application
- ANDA 212848
- Sponsor
- ALKEM LABS LTD
- Original approval
- 2021-04-01
- Listings
- 1
- Application
- ANDA 211189
- Sponsor
- GLAND
- Original approval
- 2021-05-18
- Listings
- 4
- Application
- ANDA 216725
- Sponsor
- MANKIND PHARMA
- Original approval
- 2022-09-22
- Listings
- 2
- Application
- ANDA 217029
- Sponsor
- HAINAN POLY
- Original approval
- 2023-02-01
- Listings
- 1
- Application
- ANDA 217519
- Sponsor
- EUGIA PHARMA
- Original approval
- 2023-06-21
- Listings
- 1
- Application
- ANDA 214478
- Sponsor
- MANKIND PHARMA
- Original approval
- 2023-06-30
- Listings
- 2
- Application
- ANDA 217344
- Sponsor
- MICRO LABS
- Original approval
- 2023-07-27
- Listings
- 1
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050555 | NOVARTIS | 1981-11-25 | 1 |
| ANDA 062535 | SANDOZ | 1984-12-13 | 2 |
| ANDA 063111 | HOSPIRA | 1991-04-30 | 1 |
| ANDA 064052 | BAUSCH AND LOMB INC | 1993-11-29 | 8 |
| ANDA 064096 | EPIC PHARMA LLC | 1996-01-31 | 1 |
| NDA 050753 | VIATRIS | 1997-12-22 | 1 |
| ANDA 065013 | XGEN PHARMS | 2001-08-17 | 1 |
| ANDA 065122 | FRESENIUS KABI USA | 2002-11-29 | 2 |
| NDA 050789 | FRESENIUS KABI USA | 2004-07-13 | 2 |
| ANDA 065407 | MYLAN LABS LTD | 2008-03-11 | 2 |
| NDA 201820 | CHIESI | 2012-10-12 | 2 |
| NDA 201688 | VIATRIS | 2013-03-22 | 1 |
| ANDA 091589 | TEVA PHARMS USA | 2013-10-10 | 1 |
| ANDA 201422 | HIKMA | 2014-05-28 | 1 |
| NDA 205433 | PULMOFLOW INC | 2014-12-02 | 2 |
| ANDA 205501 | AMNEAL PHARMS | 2015-07-13 | 1 |
| ANDA 206965 | BAXTER HLTHCARE CORP | 2016-07-01 | 2 |
| ANDA 208964 | LUPIN | 2017-03-22 | 1 |
| ANDA 207444 | SOMERSET THERAPS LLC | 2017-06-28 | 10 |
| ANDA 207080 | DR REDDYS LABS SA | 2018-07-09 | 2 |
| ANDA 211847 | ALEMBIC | 2019-04-19 | 2 |
| ANDA 207136 | SUN PHARM | 2019-12-26 | 2 |
| ANDA 210871 | LUOXIN AUROVITAS | 2021-01-22 | 1 |
| ANDA 209346 | GLAND | 2021-02-09 | 1 |
| ANDA 209621 | GLAND | 2021-02-11 | 2 |
| ANDA 212628 | GLAND | 2021-03-09 | 3 |
| ANDA 212848 | ALKEM LABS LTD | 2021-04-01 | 1 |
| ANDA 211189 | GLAND | 2021-05-18 | 4 |
| ANDA 216725 | MANKIND PHARMA | 2022-09-22 | 2 |
| ANDA 217029 | HAINAN POLY | 2023-02-01 | 1 |
| ANDA 217519 | EUGIA PHARMA | 2023-06-21 | 1 |
| ANDA 214478 | MANKIND PHARMA | 2023-06-30 | 2 |
| ANDA 217344 | MICRO LABS | 2023-07-27 | 1 |
Official labeling on DailyMed
- TOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC] · version 8 · 2026-08-27
- TOBRAMYCIN SOLUTION [LIFESTAR PHARMA LLC] · version 7 · 2026-08-03
- TOBRAMYCIN SOLUTION [NORTHSTAR RXLLC] · version 2 · 2026-08-03
- TOBRAMYCIN SOLUTION [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-17
- TOBRAMYCIN INHALATION SOLUTION INHALANT [NORTHSTAR RXLLC] · version 7 · 2026-07-13
- TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC] · version 4 · 2026-07-06
- TOBI (TOBRAMYCIN) SOLUTION [VIATRIS SPECIALTY LLC] · version 7 · 2026-06-29
- TOBRAMYCIN SOLUTION/ DROPS [ST. MARY'S MEDICAL PARK PHARMACY] · version 4 · 2026-06-23
- TOBI PODHALER (TOBRAMYCIN) CAPSULE [VIATRIS SPECIALTY LLC] · version 13 · 2026-06-18
- TOBRAMYCIN INJECTION, SOLUTION [HOSPIRA, INC.] · version 22 · 2026-04-14
- TOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA, INC.] · version 11 · 2026-04-08
- TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XIROMED LLC] · version 12 · 2026-03-26
Showing the 12 most recent of 63 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.