Application 064120

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEPOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATESOLUTION/DROPS;OPHTHALMIC10,000 UNITS/ML;EQ 1MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEPOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064120-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A064120-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A064120-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064120-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064120-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064120-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064120-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064120-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064120-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064120-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064120-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064120-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064120-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064120-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064120-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064120-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064120-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064120-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064120-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064120-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064120-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064120-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064120-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064120-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064120-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064120-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064120-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064120-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064120-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064120-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064120-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064120-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064120-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064120-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064120-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064120-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064120-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064120-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064120-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064120-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064120-001AT1f41ea6bd6efb…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPreferred Pharmaceuticals Inc.31a7ad1f-3f58-41a0-94f0-36674285bb612026-03-02Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
ndc (product): 68788-8152
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATESportpharm LLC476b8c6d-44e2-47e3-a75c-b4328dfe82a12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEBausch & Lomb Incorporated87999254-1857-4d3c-817a-cb8f6a5b0cf72026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
ndc (product): 24208-315
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATENuCare Pharmaceuticals,Inc.55e1f68a-836b-5c23-e054-00144ff88e882025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
ndc (product): 68071-1651
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEProficient Rx LPd1f55327-156f-44cd-b0fc-b1a938e8aa732022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
ndc (product): 63187-631

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
50090-2398Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateA-S Medication SolutionsANDACurrent
50436-4335Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateUnit Dose ServicesANDACurrent
53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53217-244Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateAidarex Pharmaceuticals LLCANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8152Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfatePreferred Pharmaceuticals Inc.ANDACurrent
70518-0271Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateREMEDYREPACK INC.ANDACurrent