Application 065085

Type: ANDA
Sponsor: TEVA

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
A065085-001	MUPIROCIN	MUPIROCIN	2%	OINTMENT / TOPICAL	AB		2003-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065085-001	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	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065085-001	MUPIROCIN	2%	OINTMENT / TOPICAL	AB	2003-11-07	`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	A065085-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065085-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065085-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065085-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065085-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065085-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065085-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065085-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065085-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065085-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065085-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065085-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065085-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065085-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065085-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065085-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065085-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065085-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065085-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065085-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065085-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065085-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065085-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065085-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065085-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065085-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065085-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065085-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065085-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065085-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065085-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065085-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065085-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065085-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065085-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065085-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065085-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065085-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065085-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065085-001	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUPIROCIN	MUPIROCIN	DIRECT RX	f88eea1a-2ba1-48bf-96c8-d96d18752aaa	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085 ndc (product): 61919-158
Mupirocin	MUPIROCIN	Advanced Rx Pharmacy of Tennessee, LLC	f1a048d9-af57-a4a2-e053-2995a90a8663	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085
Mupirocin	MUPIROCIN	Proficient Rx LP	cbb18010-f3b5-4ed7-8c03-c9203f0e360e	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085 ndc (product): 63187-525
Mupirocin	MUPIROCIN	Teva Pharmaceuticals USA, Inc.	a543797a-2c1c-4ea3-bd6c-227a784f92d9	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065085 application number: ANDA065085 ndc (product): 0093-1010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1010	Mupirocin	Mupirocin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1010	Mupirocin	Mupirocin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1010	Mupirocin	Mupirocin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42254-137	Mupirocin	Mupirocin	Rebel Distributors Corp	ANDA	Current
45865-722	Mupirocin	Mupirocin	Medsource Pharmaceuticals	ANDA	Current
50090-1929	Mupirocin	Mupirocin	A-S Medication Solutions	ANDA	Current
50436-1010	Mupirocin	Mupirocin	Unit Dose Services	ANDA	Current
53002-9852	Mupirocin	Mupirocin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-333	Mupirocin	Mupirocin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-158	MUPIROCIN	MUPIROCIN	DIRECT RX	ANDA	Current
61919-158	MUPIROCIN	MUPIROCIN	DIRECT RX	ANDA	Current
63187-525	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current
63187-525	Mupirocin	Mupirocin	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42807	ORIG	2007-04-02