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 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A065192-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2005-11-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A065192-001	AB	1	`e64feba35796…`

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	6c9cd7fc-b72e-406e-b9aa-0f1bc035b832	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Preferred Pharmaceuticals Inc.	06a4ee22-d8f8-4a8a-8666-82b14f2d8476	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	HAWAII REPACK, INC.	7eaa296c-3f98-4f11-b4c1-62c2bc22a9a1	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	St. Mary's Medical Park Pharmacy	235c4f77-e751-a69f-e063-6394a90a1f96	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN CALCIUM	REMEDYREPACK INC.	9a1be092-6fe8-4b7c-a668-e584783f888b	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Mupirocin
Mupirocin	MUPIROCIN	Sportpharm LLC	c70dd5d7-6995-4a3d-b19c-9b4a2cfe3da9	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Sportpharm LLC	e250adda-52a5-486f-a43d-2cc486dbe2a8	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN CALCIUM	Sun Pharmaceutical Industries, Inc.	6719ffba-3430-4fa9-b65b-c5c195ee1b35	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Mupirocin
Mupirocin	MUPIROCIN CALCIUM	NORTHSTAR RX LLC	6f1c0789-4a3b-473a-96d6-0c479ee32d36	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Mupirocin
MUPIROCIN	MUPIROCIN	DIRECT RX	f88eea1a-2ba1-48bf-96c8-d96d18752aaa	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: MUPIROCIN generic name: MUPIROCIN
Mupirocin	MUPIROCIN	PAI Holdings, LLC dba PAI Pharma	a822d44d-c651-406c-a2b9-aa8fbe8f89ce	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Redpharm Drug	49eb7289-c44d-75e1-e063-6294a90a2283	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: MUPIROCIN generic name: MUPIROCIN
mupirocin	MUPIROCIN	REMEDYREPACK INC.	290b4e51-59b4-429a-987b-715ac817ef2c	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	AvPAK	8b10c706-ae9c-fc76-e053-2a95a90a4c73	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Glenmark Pharmaceuticals Inc., USA	ff7428fb-9ce9-4743-b58c-01a05424a57a	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	6cef3abf-9f17-459e-86b9-95896d9620b7	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
mupirocin	MUPIROCIN	Bryant Ranch Prepack	7e7675fb-4bfa-46ac-ac1b-0918593d63ee	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: mupirocin generic name: MUPIROCIN
MUPIROCIN	MUPIROCIN	Encube Ethicals, Inc.	95c302b8-affa-431a-9b89-0506f5a098e6	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: MUPIROCIN generic name: MUPIROCIN
Mupirocin	MUPIROCIN	Encube Ethicals, Inc.	cb085bdf-e371-6e8a-e053-2995a90ae358	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Mupirocin generic name: MUPIROCIN
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

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