Application 206255

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOOLANTRA	IVERMECTIN	CREAM;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N206255-001	SOOLANTRA	IVERMECTIN	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206255-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N206255-001	10206939	2034-03-13	U-1631	2019-02-19
N206255-001	9089587	2034-03-13	U-1631	2015-07-31
N206255-001	9233117	2034-03-13	U-1631	2016-01-19
N206255-001	9233118	2034-03-13	U-1631	2016-01-19
N206255-001	9782425	2034-03-13	U-1631	2018-01-05

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL		RLD, RS	2014-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL		RLD, RS	2014-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`cb3db0bc1861…`

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	N206255-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206255-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206255-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206255-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206255-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206255-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206255-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206255-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 446 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	11033565	2024-04-22		Drug product	2021-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	7550440	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8080530	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8093219	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8415311	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8470788	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8815816	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	11033565	2024-04-22		Drug product	2021-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	7550440	2024-04-22	U-1631	Drug product	2015-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	8080530	2024-04-22	U-1631	Drug product	2015-01-20	`2680178bc6a6…`

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
SOOLANTRA	IVERMECTIN	Galderma Laboratories, L.P.	b1d5b166-ab06-4ab5-b0c6-31126238118a	2024-10-24	Adverse reactions	Exact identifier application applno (NDA): 206255 application number: NDA206255 ndc (product): 0299-3823
IVERMECTIN	IVERMECTIN	Mayne Pharma Inc.	39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd	2023-08-29	Adverse reactions	Exact identifier application applno (NDA): 206255 application number: NDA206255

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-3823	SOOLANTRA	IVERMECTIN	Galderma Laboratories, L.P.	NDA	Current
0299-3823	SOOLANTRA	IVERMECTIN	Galderma Laboratories, L.P.	NDA	Current
0299-3823	SOOLANTRA	IVERMECTIN	Galderma Laboratories, L.P.	NDA	Current
0574-2107	Ivermectin	IVERMECTIN	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
0574-2107	Ivermectin	IVERMECTIN	Paddock Laboratories, LLC.	NDA AUTHORIZED GENERIC	Current
0574-2107	Ivermectin	IVERMECTIN	Paddock Laboratories, LLC.	NDA AUTHORIZED GENERIC	Current
66993-948	Ivermectin	IVERMECTIN	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-948	Ivermectin	IVERMECTIN	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72396	SUPPL	2022-10-17
72395	SUPPL	2022-10-17
72355	SUPPL	2022-10-17
72354	SUPPL	2022-10-17
53785	SUPPL	2018-04-23
53748	SUPPL	2018-04-20
24512	ORIG	2016-03-23
23016	ORIG	2016-03-23
40531	ORIG	2015-01-08
10553	ORIG	2014-12-24