Application 060733

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACITRACINBACITRACININJECTABLE;INJECTION10,000 UNITS/VIALNoNo
002BACITRACINBACITRACININJECTABLE;INJECTION50,000 UNITS/VIALNoYes

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAPRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAPRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982ea99ee380514…
2022-09-29 23:25 UTC2022-09A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A060733-001BACITRACIN10,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A060733-002BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A060733-002AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A060733-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A060733-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A060733-002AP1ea99ee380514…

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsName fallback
brand name: Bacitracin
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsName fallback
brand name: Bacitracin
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
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsName fallback
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsName fallback
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsName fallback
brand name: Bacitracin
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
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsName fallback
brand name: Bacitracin
generic name: BACITRACIN
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2025-06-20WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsName fallback
brand 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
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsName fallback
brand name: Bacitracin
generic name: BACITRACIN
BacitracinBACITRACINDynarex Corporation7f8752c7-6839-261d-e053-2991aa0a0c302024-11-20WarningsName fallback
brand name: Bacitracin
generic name: BACITRACIN
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsName fallback
brand name: BACITRACIN
generic name: BACITRACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0233BacitracinBacitracinPharmacia and Upjohn CompanyANDACurrent
0009-0233BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0233BacitracinBacitracinPharmacia & Upjohn Company LLCANDACurrent
0009-0233BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0233BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0233BacitracinBacitracinPharmacia and Upjohn CompanyANDACurrent
0009-0233BacitracinBacitracinPharmacia & Upjohn Company LLCANDACurrent
0009-0233BacitracinBacitracinPharmacia and Upjohn CompanyANDACurrent
0009-0233BacitracinBacitracinPharmacia & Upjohn Company LLCANDACurrent
0009-0234BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0234BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0234BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0241BacitracinBacitracinPharmacia and Upjohn CompanyANDACurrent
0009-0241BacitracinBacitracinPharmacia and Upjohn Company LLCANDACurrent
0009-0241BacitracinBacitracinPharmacia and Upjohn CompanyANDACurrent