Application 062938

Type
ANDA
Sponsor
PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoNo

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

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
A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062938-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062938-001AT1cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062938
application number: ANDA062938
ndc (product): 63187-395

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-4160Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePaddock Laboratories, LLCANDACurrent
0574-4160Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePadagis US LLCANDACurrent
26637-941Neomycin and Polymyxin B Sulfates and DexamethasoneDexamethasone, Neomycin sulfate, Polymysin B sulfatePutney, Inc.ANDACurrent
50090-0571Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneA-S Medication SolutionsANDACurrent
53217-289Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneAidarex Pharmaceuticals LLCANDACurrent
61919-113NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEneomycin, polymyxin b sulfates, dexamethasoneDIRECT RXANDACurrent
61919-113NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEneomycin, polymyxin b sulfates, dexamethasoneDIRECT RXANDACurrent
63187-395Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneProficient Rx LPANDACurrent
63187-395Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneProficient Rx LPANDACurrent
68071-1744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9373Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9373Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9373Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9373Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent