Application 064135

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXASPORINDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESUSPENSION/DROPS;OPHTHALMIC0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064135-001DEXASPORINDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A064135-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-133f01610625f2…
2019-09-15 20:21 UTC2019-09A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064135-001DEXASPORIN0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OPHTHALMICAT1995-09-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064135-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064135-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064135-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064135-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064135-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064135-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064135-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064135-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064135-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064135-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064135-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064135-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064135-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064135-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064135-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064135-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064135-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064135-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064135-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064135-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064135-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064135-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064135-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064135-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064135-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064135-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064135-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064135-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064135-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064135-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064135-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064135-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064135-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064135-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064135-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064135-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064135-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064135-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064135-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064135-001AT1cb3db0bc1861…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEA-S Medication Solutionsadcc540e-9275-4a7c-918a-36fa2314acd22026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 50090-0570
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEPreferred Pharmaceuticals, Inc.449a6fd8-c2ac-40d0-b74a-e5c7fc6670f32025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 68788-9702
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPSDirectRxd5e00bad-abb4-63ad-e053-2a95a90a5abb2025-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 72189-320
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEBausch & Lomb Incorporatedd6d78668-a978-4cd3-bbcd-1293b5044ec92024-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 24208-830
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 68071-4375
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEProficient Rx LP548089f3-29d8-4ba8-af21-9e04356ac29c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064135
application number: ANDA064135
ndc (product): 63187-498

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1403NEO-POLY-DEXNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneButler Animal Health SupplyANDACurrent
13985-028Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneMWI/VetOneANDACurrent
24208-830Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-830Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneBausch & Lomb IncorporatedANDACurrent
45865-796Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasonemedsource pharmaceuticalsANDACurrent
50090-0570Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneA-S Medication SolutionsANDACurrent
50090-0570Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneA-S Medication SolutionsANDACurrent
52959-085Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneH.J. Harkins Company, Inc.ANDACurrent
53002-9510Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-9510Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneRPK Pharmaceuticals, Inc.ANDACurrent
57319-347Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePhoenix Pharmaceutical, Inc.ANDACurrent
61919-167NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONEDIRECT RXANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
66267-958Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4375Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4375Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
72189-320NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONEneomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ dropsDirectRxANDACurrent