Application 050591

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTROBAN	MUPIROCIN	OINTMENT;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050591-001	BACTROBAN	MUPIROCIN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1987-12-31

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050591-001	BACTROBAN	2%	OINTMENT / TOPICAL	RLD	1987-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050591-001	BACTROBAN	2%	OINTMENT / TOPICAL	RLD	1987-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	831060e6-17ef-b0a0-e053-2991aa0aeb4f	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	6c9cd7fc-b72e-406e-b9aa-0f1bc035b832	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	06a4ee22-d8f8-4a8a-8666-82b14f2d8476	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	HAWAII REPACK, INC.	7eaa296c-3f98-4f11-b4c1-62c2bc22a9a1	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	St. Mary's Medical Park Pharmacy	235c4f77-e751-a69f-e063-6394a90a1f96	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Sportpharm LLC	c70dd5d7-6995-4a3d-b19c-9b4a2cfe3da9	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Sportpharm LLC	e250adda-52a5-486f-a43d-2cc486dbe2a8	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	DIRECT RX	f88eea1a-2ba1-48bf-96c8-d96d18752aaa	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	PAI Holdings, LLC dba PAI Pharma	a822d44d-c651-406c-a2b9-aa8fbe8f89ce	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Redpharm Drug	49eb7289-c44d-75e1-e063-6294a90a2283	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	REMEDYREPACK INC.	290b4e51-59b4-429a-987b-715ac817ef2c	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	AvPAK	8b10c706-ae9c-fc76-e053-2a95a90a4c73	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Glenmark Pharmaceuticals Inc., USA	ff7428fb-9ce9-4743-b58c-01a05424a57a	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	6cef3abf-9f17-459e-86b9-95896d9620b7	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	7e7675fb-4bfa-46ac-ac1b-0918593d63ee	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Encube Ethicals, Inc.	95c302b8-affa-431a-9b89-0506f5a098e6	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Encube Ethicals, Inc.	cb085bdf-e371-6e8a-e053-2995a90ae358	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Sun Pharmaceutical Industries, Inc.	900bb675-2f03-47e3-854e-257ec4831332	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	ATLANTIC BIOLOGICALS CORP.	da2f7d4e-82c6-4790-8eea-3a97e5b30734	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Lohxa	6d59e35c-b262-7940-e053-2991aa0a8908	2025-03-25	Warnings, Adverse reactions	Name 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
Document	Submission type	Date
48344	SUPPL	2017-05-10
48318	SUPPL	2017-05-09
39021	SUPPL	2015-12-15
39019	SUPPL	2015-03-20
30139	SUPPL	2015-03-20
39020	SUPPL	2014-05-28
7862	SUPPL	2014-05-27
22165	SUPPL	2002-07-12
30138	SUPPL	1999-04-22