FDA.reportPublic FDA data

Application 050591

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACTROBANMUPIROCINOINTMENT;TOPICAL2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N050591-001BACTROBANMUPIROCIN2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1987-12-31

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050591-001BACTROBAN2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1987-12-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050591-001BACTROBAN2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1987-12-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050591-001BACTROBAN2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1987-12-31a50c72e98297…

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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mupirocinMUPIROCINNuCare Pharmaceuticals,Inc.831060e6-17ef-b0a0-e053-2991aa0aeb4f2026-08-20Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINPreferred Pharmaceuticals Inc.6c9cd7fc-b72e-406e-b9aa-0f1bc035b8322026-07-28Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINPreferred Pharmaceuticals Inc.06a4ee22-d8f8-4a8a-8666-82b14f2d84762026-07-28Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINHAWAII REPACK, INC.7eaa296c-3f98-4f11-b4c1-62c2bc22a9a12026-07-27Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINSt. Mary's Medical Park Pharmacy235c4f77-e751-a69f-e063-6394a90a1f962026-06-10Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINSportpharm LLCc70dd5d7-6995-4a3d-b19c-9b4a2cfe3da92026-05-12Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINSportpharm LLCe250adda-52a5-486f-a43d-2cc486dbe2a82026-05-04Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MUPIROCINMUPIROCINDIRECT RXf88eea1a-2ba1-48bf-96c8-d96d18752aaa2026-03-20Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINPAI Holdings, LLC dba PAI Pharmaa822d44d-c651-406c-a2b9-aa8fbe8f89ce2026-03-17Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MUPIROCINMUPIROCINRedpharm Drug49eb7289-c44d-75e1-e063-6294a90a22832026-02-03Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINREMEDYREPACK INC.290b4e51-59b4-429a-987b-715ac817ef2c2026-01-28Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINAvPAK8b10c706-ae9c-fc76-e053-2a95a90a4c732026-01-20Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINGlenmark Pharmaceuticals Inc., USAff7428fb-9ce9-4743-b58c-01a05424a57a2025-10-28Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINBryant Ranch Prepack6cef3abf-9f17-459e-86b9-95896d9620b72025-10-24Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINBryant Ranch Prepack7e7675fb-4bfa-46ac-ac1b-0918593d63ee2025-10-08Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MUPIROCINMUPIROCINEncube Ethicals, Inc.95c302b8-affa-431a-9b89-0506f5a098e62025-10-08Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINEncube Ethicals, Inc.cb085bdf-e371-6e8a-e053-2995a90ae3582025-09-26Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINSun Pharmaceutical Industries, Inc.900bb675-2f03-47e3-854e-257ec48313322025-07-07Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
mupirocinMUPIROCINATLANTIC BIOLOGICALS CORP.da2f7d4e-82c6-4790-8eea-3a97e5b307342025-05-28Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN
MupirocinMUPIROCINLohxa6d59e35c-b262-7940-e053-2991aa0a89082025-03-25Warnings, Adverse reactionsName fallback
generic name: MUPIROCIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48344SUPPL2017-05-10
48318SUPPL2017-05-09
39021SUPPL2015-12-15
39019SUPPL2015-03-20
30139SUPPL2015-03-20
39020SUPPL2014-05-28
7862SUPPL2014-05-27
22165SUPPL2002-07-12
30138SUPPL1999-04-22