Application 062814

Type
ANDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 0.8MG BASE/MLNoNo
002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.2MG BASE/MLNoNo
003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.4MG BASE/MLNoNo
004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.6MG BASE/MLNoNo
005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 1.8MG BASE/MLNoNo
006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo
007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 2.4MG BASE/MLNoNo
008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 40MG BASE/100MLNoNo
009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 60MG BASE/100MLNoNo
010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 70MG BASE/100MLNoNo
011GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 80MG BASE/100MLNoNo
012GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 90MG BASE/100MLNoNo
013GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 100MG BASE/100MLNoNo
014GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 120MG BASE/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 14 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062814-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 0.8MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.2MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.4MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.6MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.8MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 2MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 2.4MG BASE/MLINJECTABLE / INJECTION1987-08-28
A062814-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 40MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 60MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 70MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-011GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 80MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-012GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 90MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-013GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 100MG BASE/100MLINJECTABLE / INJECTION1987-08-28
A062814-014GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 120MG BASE/100MLINJECTABLE / INJECTION1987-08-28

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.

Product history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062814-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.4MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.8MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 70MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-011GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-012GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 90MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-013GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A062814-014GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTION1987-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062814-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.4MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.8MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 70MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-011GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-012GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 90MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-013GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062814-014GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTION1987-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.4MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.8MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 70MG BASE/100MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-011GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062814-012GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 90MG BASE/100MLINJECTABLE / INJECTION1987-08-2831067a03dcf5…

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 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEHenry Schein, Inc84f6eb1c-a287-489a-8c3e-aa5954cf19922025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEHenry Schein, Inc.913a36c3-50d6-429a-a8dd-a03126d2ca082025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC84f5c763-1cd3-4d85-9afb-934db8666fbf2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE