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001	BACTROBAN	MUPIROCIN	OINTMENT;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N050591-001	BACTROBAN	MUPIROCIN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1987-12-31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N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`84e616aacf4f…`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N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`caaa826d4ba7…`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UTC	2026-02	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`011fe1cb6892…`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of this ZIP	2025-12	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`31067a03dcf5…`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UTC	2025-08	N050591-001	BACTROBAN	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD	1987-12-31	`6a471c1ec25d…`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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUPIROCIN	MUPIROCIN	Alembic Pharmaceuticals Limited	0580458d-7178-4031-8ac7-0cda281ade8b	2025-03-18	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	5abf8c5c-e9c9-3b59-e053-2a91aa0ae394	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a048d9-af57-a4a2-e053-2995a90a8663	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a01044-8f2e-4e91-e053-2995a90af722	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	66db1071-024f-aa19-e053-2a91aa0a8e39	2024-06-06	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	A-S Medication Solutions	a6c22c25-0f02-4c06-bbc2-723a18ecdda8	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Padagis Israel Pharmaceuticals Ltd	e9b61f01-3c67-42a4-a62b-10f1d1343190	2023-12-31	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Alembic Pharmaceuticals Inc.	a69cd608-d2e6-4a7a-8cd7-f761bd333542	2023-12-11	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0	2023-11-01	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	1cd4c71f-138b-47c2-8ce8-9ac32408dc56	2023-07-18	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	d8766748-6b53-4673-a3ee-5cd8a4301647	2023-01-01	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	cbb18010-f3b5-4ed7-8c03-c9203f0e360e	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Teva Pharmaceuticals USA, Inc.	a543797a-2c1c-4ea3-bd6c-227a784f92d9	2022-05-01	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Proficient Rx LP	97f8d67d-c422-4a26-9394-24a5ec9719d9	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Amneal Pharmaceuticals NY LLC	648fe68b-da2d-47cc-b4d2-905d0ea588a5	2021-12-30	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
mupirocin	MUPIROCIN	Asclemed USA, Inc.	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	2020-11-09	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Glenmark Pharmaceuticals Inc., USA	acd6e23e-d83f-4ed8-9c50-467ed422a8c4	2020-03-20	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN
Pirnuo	MUPIROCIN	Glenmark Pharmaceuticals Inc., USA	89c43f7b-1a88-45bf-a356-07518d4e7870	2020-03-20	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