Home Applications 064093 Application 064093
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GENTAMICIN SULFATE GENTAMICIN SULFATE OINTMENT;OPHTHALMIC EQ 0.3% BASE No Yes
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 A064093-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31
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 2 · 41 observed 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 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 cb3db0bc1861…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-284 Gentak Gentamicin Sulfate Akorn, Inc. ANDA Current 17478-284 Gentak Gentamicin Sulfate Akorn ANDA Current 17478-284 Gentak Gentamicin Sulfate Akorn, Inc. ANDA Current 17478-284 Gentak Gentamicin Sulfate Akorn ANDA Current 17478-827 Gentak Gentamicin Sulfate Akorn, Inc. ANDA Current 17478-827 Gentak Gentamicin Sulfate Akorn, Inc. ANDA Current 17478-827 Gentak Gentamicin Sulfate Akorn ANDA Current 49999-159 Gentak Gentamicin Sulfate Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ANDA Current 50090-0251 Gentak Gentamicin Sulfate A-S Medication Solutions ANDA Current 50090-0251 Gentak Gentamicin Sulfate A-S Medication Solutions ANDA Current 50090-4770 Gentak Gentamicin Sulfate A-S Medication Solutions ANDA Current 63187-873 Gentak Gentamicin Sulfate Proficient Rx LP ANDA Current 63187-873 Gentak Gentamicin Sulfate Proficient Rx LP ANDA Current 68071-1513 Gentak Gentamicin Sulfate NuCare Pharmaceuticals,Inc. ANDA Current 68071-1513 Gentak Gentamicin Sulfate NuCare Pharmaceuticals,Inc. ANDA Current 68788-9732 Gentak Gentamicin Sulfate Preferred Pharmaceuticals, Inc. ANDA Current 68788-9732 Gentak Gentamicin Sulfate Preferred Pharmaceuticals, Inc. ANDA Current 68788-9732 Gentak Gentamicin Sulfate Preferred Pharmaceuticals, Inc. ANDA Current 70518-0633 Gentak Gentamicin Sulfate REMEDYREPACK INC. ANDA Current 70518-0633 Gentak Gentamicin Sulfate REMEDYREPACK INC. ANDA Current