FDA.reportPublic FDA data

Application 064068

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A064068-001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-10-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064068-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064068-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064068-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064068-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064068-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064068-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064068-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064068-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064068-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064068-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064068-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064068-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064068-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A064068-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064068-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064068-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064068-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064068-001AT1cb3db0bc1861…

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, Bacitracin Zinc and HydrocortisoneNEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONEBausch & Lomb Incorporated3b00eb5c-dd98-467e-a883-04c37a8ecc422025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064068
application number: ANDA064068
ndc (product): 24208-785

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1406NEO-POLY-BAC HYDRONeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneButler Animal Health SupplyANDACurrent
13985-016Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneMWI/VetOneANDACurrent
13985-745Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneMWIANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
57319-344Triple Antibiotic HCNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisonePhoenix Pharmaceutical, Inc.ANDACurrent