Application 021307

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	CREAM;TOPICAL	1%	Yes	Yes

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
N021307-001	LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL		RLD, RS	2001-12-07

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`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
Lotrimin Ultra Jock Itch	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	9dfa08fb-0913-4326-b1eb-1425df6a2c82	2025-12-05	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307 ndc (product): 11523-4339
Lotrimin Ultra Athletes Foot	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	e258c4ac-53ef-4a99-b732-4985f890b938	2025-12-05	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307 ndc (product): 11523-4338
Lotrimin Ultra	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	2025-12-04	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307 ndc (product): 11523-0082
Lotrimin Ultra Ringworm	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	1b438ca7-fd5f-62cb-e063-6294a90ab3a6	2025-12-04	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307

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
11523-0082	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-0082	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-0082	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4338	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4338	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4338	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4338	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4338	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4339	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4339	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-4339	Lotrimin Ultra	Butenafine hydrochloride	Bayer Healthcare LLC.	NDA	Current
11523-7154	Lotrimin Ultra	Butenafine Hydrochloride	Bayer HealthCare LLC.	NDA	Current
11523-7155	Lotrimin Ultra Jock Itch	Butenafine Hydrochloride	Bayer HealthCare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79040	SUPPL	2024-07-11
79039	SUPPL	2024-07-11
78194	SUPPL	2024-04-22
78186	SUPPL	2024-04-22
77186	SUPPL	2024-01-04
77178	SUPPL	2024-01-04
75332	SUPPL	2023-08-31
75322	SUPPL	2023-08-30
69536	SUPPL	2021-12-13
69039	SUPPL	2021-10-20
65702	SUPPL	2020-12-23
65700	SUPPL	2020-12-23
15161	SUPPL	2015-12-22
4995	SUPPL	2015-12-22
27445	SUPPL	2014-12-18
4994	SUPPL	2012-05-04
27444	SUPPL	2011-04-04
4993	SUPPL	2006-04-07
21588	ORIG	2002-03-26
36631	ORIG	2001-12-07
4992	ORIG	2001-12-07