Home Applications 217029 Application 217029
Type ANDA
Sponsor SLATE RUN PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE INJECTABLE;INJECTION EQ 1.2GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217029-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217029-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join tobramycin TOBRAMYCIN Slate Run Pharmaceuticals, LLC ed254eec-10f4-425a-895b-66e325b7bf69 2026-02-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217029 application number: ANDA217029