FDA.reportPublic FDA data

Application 061212

Type
ANDA
Sponsor
PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACITRACINBACITRACINOINTMENT;OPHTHALMIC500 UNITS/GMNoYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061212-001BACITRACINBACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsName fallback
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsName fallback
BacitracinBACITRACINPreferred Pharmaceuticals, Inc5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd92026-03-16WarningsName fallback
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsName fallback
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsName fallback
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsName fallback
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsName fallback
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsName fallback
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsName fallback
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsName fallback
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsName fallback
BacitracinBACITRACINDynarex Corporation7f8752c7-6839-261d-e053-2991aa0a0c302024-11-20WarningsName fallback
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsName fallback
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsName fallback
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsName fallback
BACITRACINBACITRACINCVS Pharmacy15ea4415-943a-4d0a-ac23-5f37cd2cf2062024-10-22WarningsName fallback
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsName fallback
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsName fallback
BacitracinBACITRACINPadagis Israel Pharmaceuticals Ltdbebbedf6-dd65-47a4-aa3e-ad197b3e05a12024-07-31WarningsName fallback
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsName fallback

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For External Use Only. Do not use; in eyes, over large areas of the body, if you are allergic to any of the ingredients, longer than 1 week unless directed by a doctor. .

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-4022BacitracinBacitracinPaddock Laboratories, LLCANDACurrent
0574-4022BacitracinBacitracinPadagis US LLCANDACurrent
0574-4022BacitracinBacitracinPadagis US LLCANDACurrent
0574-4022BacitracinBacitracinPaddock Laboratories, LLCANDACurrent
42254-003BACITRACINBACITRACINRebel Distributors CorpANDACurrent
69784-880BACIGUENTBacitracinWoodward Pharma Services LLCANDACurrent
69784-880BACIGUENTBacitracinWoodward Pharma Services LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73849SUPPL 2023-03-24
73848SUPPL 2023-03-24
73847SUPPL 2023-03-24
73846SUPPL 2023-03-24
73845SUPPL 2023-03-24
73844SUPPL 2023-03-24
73843SUPPL 2023-03-24
73842SUPPL 2023-03-24
57671ORIG2019-02-15