Application 050788

Type: NDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CENTANY	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
N050788-001	CENTANY	MUPIROCIN	2%	OINTMENT / TOPICAL			2002-12-04

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	N050788-001	CENTANY	2%	OINTMENT / TOPICAL		2002-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050788-001	CENTANY	2%	OINTMENT / TOPICAL	BX	2002-12-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050788-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050788-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050788-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050788-001	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050788-001	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050788-001	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050788-001	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050788-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050788-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050788-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050788-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050788-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050788-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050788-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050788-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050788-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050788-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050788-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050788-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050788-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050788-001	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050788-001	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050788-001	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050788-001	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050788-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050788-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050788-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050788-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050788-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050788-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050788-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050788-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050788-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050788-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050788-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050788-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050788-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050788-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050788-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050788-001	BX	1	`cb3db0bc1861…`

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	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
MUPIROCIN	MUPIROCIN	Alembic Pharmaceuticals Limited	0580458d-7178-4031-8ac7-0cda281ade8b	2025-03-18	Warnings, Adverse reactions	Name fallback generic name: MUPIROCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43538-300	CENTANY	mupirocin	Medimetriks Pharmaceuticals Inc	NDA	Current
43538-310	Centany	Mupirocin	Medimetriks Pharmaceuticals, Inc.	NDA	Current
43538-310	Centany	Mupirocin	Medimetriks Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82811	SUPPL	2025-07-11
82789	SUPPL	2025-07-11
30546	SUPPL	2015-06-22
18250	SUPPL	2015-06-22
22239	ORIG	2003-04-30
18249	ORIG	2002-12-04
8292	ORIG	2002-12-04