Application 065192

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MUPIROCIN	MUPIROCIN	OINTMENT;TOPICAL	2%	No	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
A065192-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		2005-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065192-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065192-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065192-001	AB	1	`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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mupirocin	MUPIROCIN	Sun Pharmaceutical Industries, Inc.	900bb675-2f03-47e3-854e-257ec4831332	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	ATLANTIC BIOLOGICALS CORP.	da2f7d4e-82c6-4790-8eea-3a97e5b30734	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN OINTMENT	Kesin Pharma Corporation	b8e115ce-c8ff-4d08-b865-71dc4d0e51a1	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Mupirocin
Mupirocin	MUPIROCIN	Lohxa	6d59e35c-b262-7940-e053-2991aa0a8908	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Alembic Pharmaceuticals Limited	0580458d-7178-4031-8ac7-0cda281ade8b	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: MUPIROCIN generic name: MUPIROCIN
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	5abf8c5c-e9c9-3b59-e053-2a91aa0ae394	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a048d9-af57-a4a2-e053-2995a90a8663	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a01044-8f2e-4e91-e053-2995a90af722	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	NuCare Pharmaceuticals,Inc.	66db1071-024f-aa19-e053-2a91aa0a8e39	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	A-S Medication Solutions	a6c22c25-0f02-4c06-bbc2-723a18ecdda8	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Padagis Israel Pharmaceuticals Ltd	e9b61f01-3c67-42a4-a62b-10f1d1343190	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Alembic Pharmaceuticals Inc.	a69cd608-d2e6-4a7a-8cd7-f761bd333542	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: MUPIROCIN generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	1cd4c71f-138b-47c2-8ce8-9ac32408dc56	2023-07-18	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	d8766748-6b53-4673-a3ee-5cd8a4301647	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Proficient Rx LP	cbb18010-f3b5-4ed7-8c03-c9203f0e360e	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Teva Pharmaceuticals USA, Inc.	a543797a-2c1c-4ea3-bd6c-227a784f92d9	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Proficient Rx LP	97f8d67d-c422-4a26-9394-24a5ec9719d9	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Amneal Pharmaceuticals NY LLC	648fe68b-da2d-47cc-b4d2-905d0ea588a5	2021-12-30	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Asclemed USA, Inc.	b2ff9c56-ca19-48ca-bd08-4b33edb13a08	2020-11-09	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0352	Mupirocin	mupirocin	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
21695-188	Mupirocin	mupirocin	Rebel Distributors Corp.	ANDA	Current
50436-0025	Mupirocin	mupirocin	Unit Dose Services	ANDA	Current
50436-0025	Mupirocin	mupirocin	Unit Dose Services	ANDA	Current
50436-0025	Mupirocin	mupirocin	Unit Dose Services	ANDA	Current
68387-550	Mupirocin	mupirocin	Keltman Pharmaceuticals Inc.	ANDA	Current