Application 087204

Type: ANDA
Sponsor: MARNEL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CROTAN	CROTAMITON	LOTION;TOPICAL	10%	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
A087204-001	CROTAN	CROTAMITON	10%	LOTION / TOPICAL		RS, Approved before 1982

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A087204-001	CROTAN	10%	LOTION / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087204-001	CROTAN	10%	LOTION / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087204-001	CROTAN	10%	LOTION / TOPICAL		RS, Approved before 1982	`a50c72e98297…`

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	A087204-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087204-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087204-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087204-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087204-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087204-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087204-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087204-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087204-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087204-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087204-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087204-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087204-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087204-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087204-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087204-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087204-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087204-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087204-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087204-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087204-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087204-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087204-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087204-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087204-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087204-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087204-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087204-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087204-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087204-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087204-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087204-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087204-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087204-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087204-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087204-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087204-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087204-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087204-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087204-001	AT	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pruradik	CROTAMITON	Trifluent Pharma, LLC	3699175f-bfc8-a047-e063-6394a90a80d1	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087204 application number: ANDA087204
Crotan	CROTAMITON	Marnel Pharmaceuticals, Inc.	6f7478fa-ed2b-4943-9d40-1fd0161a0854	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087204 application number: ANDA087204 ndc (product): 0682-0051

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
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current
0682-0051	Crotan	Crotamiton	Marnel Pharmaceuticals, Inc.	ANDA	Current