FDA.reportPublic FDA data

Application 212991

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.1%;0.3%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212991-001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCIN0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2021-07-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212991-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMIC2021-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212991-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212991-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212991-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212991-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212991-001AB1782e0a99824c…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212991-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212991-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212991-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212991-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212991-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212991-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212991-001AB1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEREMEDYREPACK INC.c606945c-4ffc-4ee8-af04-a00de8ea92592026-06-11Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack1884ef6f-a60c-4a82-a7dc-fd48b7176db02026-05-28Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c33e84ba-4c0c-f738-e053-2995a90aa20a2026-03-27Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLC7ed85675-bc46-4dd6-bb8f-7e98c3eb84e22026-03-20Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEPreferred Pharmaceuticals Inc.8a143864-e36b-49bf-91b4-c6cc1a9280312026-02-26Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutionscdd9086d-821f-4ac8-bc49-f1869dffb1502026-01-29Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONERedpharm Drug3dd00c21-ae42-0613-e063-6394a90a80122025-12-02Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e541ebf-2f7e-4cc0-9928-780353aa76572025-10-21Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e5cd7f9-1f88-4d33-be25-c362de4dc87b2025-10-21Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack15280680-edc0-4e5d-99ee-117a6f5893072025-10-21Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESandoz Inc05fd0c36-39b4-4a43-8490-eb8dfc0920ae2025-04-07Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.b7b39ad5-e158-b8fe-e053-2995a90a52792025-02-07Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx of Tennessee, LLC09315f0b-f15a-30d5-e063-6394a90ac8dd2024-12-31Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and dexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf4c00d9c-3a17-06a0-e053-2a95a90a84132024-12-31Warnings, Adverse reactionsName fallback
brand name: Tobramycin and dexamethasone
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions8d6a8a22-fd97-43e7-a89c-b1f32710a7732024-10-14Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions11c2ba9a-7aa3-4f78-aa2f-2a35d26716812024-08-12Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsName fallback
brand name: Tobramycin and Dexamethasone
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepacka5f0b05b-3dec-4fe8-8106-e41e668a512d2024-01-12Warnings, Adverse reactionsName fallback
brand name: TOBRAMYCIN AND DEXAMETHASONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent