Application 020723

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALDARA	IMIQUIMOD	CREAM;TOPICAL	5%	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
N020723-001	ALDARA	IMIQUIMOD	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27

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2026-02-19 14:30 UTC	2026-02	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020723-001	ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1997-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020723-001	ALDARA	5%	CREAM / TOPICAL		RLD	1997-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020723-001	ALDARA	5%	CREAM / TOPICAL	AB	RLD, RS	1997-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020723-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020723-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020723-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020723-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020723-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020723-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020723-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020723-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020723-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020723-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020723-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020723-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020723-001	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020723-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020723-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020723-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020723-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020723-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020723-001	7696159	2024-04-01	U-1048	Drug substance	2010-05-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020723-001	7696159*PED	2024-10-01		Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020723-001	7696159	2024-04-01	U-1047	Drug substance	2010-05-12	`bb7c543d1eb4…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imiquimod	IMIQUIMOD	Sun Pharmaceutical Industries, Inc.	51913a5a-1cab-4b9e-b2c2-e0174062df73	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	9291e5cd-b83d-4b43-88f5-30cac6cef5ff	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	f8db59e2-8052-413b-9f9f-07cd9eea07ec	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Sun Pharmaceutical Industries, Inc.	59af8153-4cf8-4f22-9000-f239798d52d1	2025-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	47d3045f-a145-4095-bb8a-c67ba1ff3bda	2025-07-29	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Teva Pharmaceuticals USA, Inc.	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Oceanside Pharmacueticals	d86eeb0e-70e0-4c72-aaa3-37daa1d8611e	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Zyclara	IMIQUIMOD	Bausch Health US, LLC	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	2025-05-23	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Padagis Israel Pharmaceuticals Ltd	1505cf54-37da-4b2b-9812-6ffd6a01a7c7	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Glenmark Pharmaceuticals Inc., USA	663e39a9-a29e-473f-89ec-4c7c6bc27b8a	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD
IMIQUIMOD	IMIQUIMOD	DIRECT RX	a18a3f7e-7254-56c0-e053-2a95a90a7036	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: IMIQUIMOD

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
99207-260	Aldara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-260	Aldara	imiquimod	Bausch Health US LLC	NDA	Current
99207-260	Aldara	imiquimod	Bausch Health US LLC	NDA	Current
99207-260	Aldara	imiquimod	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79746	SUPPL	2024-09-26
79743	SUPPL	2024-09-26
20881	SUPPL	2012-04-13
35233	SUPPL	2010-10-19
3205	SUPPL	2010-10-19
20882	SUPPL	2007-11-19
35232	SUPPL	2007-03-31
25636	SUPPL	2007-03-31
25635	SUPPL	2005-08-11
13289	SUPPL	2005-08-11
13288	SUPPL	2004-07-21
3204	SUPPL	2004-07-21
35230	SUPPL	2004-05-26
35229	SUPPL	2004-05-26
25634	SUPPL	2004-05-26
25633	SUPPL	2004-05-26
13287	SUPPL	2004-05-26
3202	SUPPL	2004-05-26
35231	SUPPL	2004-04-05
3203	SUPPL	2004-03-03
35228	SUPPL	2003-04-22
51986	SUPPL	1900-01-01
51985	SUPPL	1900-01-01
51984	SUPPL	1900-01-01
51983	SUPPL	1900-01-01
51982	SUPPL	1900-01-01
51981	SUPPL	1900-01-01
51980	SUPPL	1900-01-01
51979	SUPPL	1900-01-01