Application 060734

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACIGUENTBACITRACINOINTMENT;OPHTHALMIC500 UNITS/GMNoNo

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
A060734-001BACIGUENTBACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982

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 UTC2026-02A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A060734-001BACIGUENT500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982cb3db0bc1861…

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsName fallback
generic name: BACITRACIN
Medi-First Bacitracin ZincBACITRACINUnifirst First Aid Corporation54609a4f-0fe9-b750-e063-6394a90ae9ce2026-05-26WarningsName fallback
generic name: BACITRACIN
first aid antibioticBACITRACINHyVee Inc97c87111-260a-48d0-92cd-e22f55a48c7d2026-05-12WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINPreferred Pharmaceuticals, Inc5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd92026-03-16WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsName fallback
generic name: BACITRACIN
Zapotol BacitracinBACITRACINZapatol Corp.c8704895-8819-49ac-8baa-5b97be1d00aa2025-10-22WarningsName fallback
generic name: BACITRACIN
MediChoice BacitracinBACITRACINO&M HALYARD, INC.78079b94-c6fc-4529-aaad-8186924ecba52025-10-09WarningsName fallback
generic name: BACITRACIN
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsName fallback
generic name: BACITRACIN
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2025-06-20WarningsName fallback
generic name: BACITRACIN
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINDynarex Corporation7f8752c7-6839-261d-e053-2991aa0a0c302024-11-20WarningsName fallback
generic name: BACITRACIN
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsName fallback
generic name: BACITRACIN
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsName fallback
generic name: BACITRACIN