Application 022483

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYCLARA	IMIQUIMOD	CREAM;TOPICAL	3.75%	Yes	Yes
002	ZYCLARA	IMIQUIMOD	CREAM;TOPICAL	2.5%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022483-001	ZYCLARA	IMIQUIMOD	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25
N022483-002	ZYCLARA	IMIQUIMOD	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022483-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022483-001	10238645	2029-08-18	U-1455	2019-04-11
N022483-001	10238645	2029-08-18	U-172	2019-04-11
N022483-001	8598196	2029-08-18	U-1455	2013-12-11
N022483-001	8598196	2029-08-18	U-172	2013-12-11
N022483-001	10238644	2029-12-11	U-68	2019-04-11
N022483-001	8236816	2029-12-11	U-68	2012-08-08
N022483-001	8299109	2029-12-11	U-68	2012-11-01
N022483-001	10918635	2030-04-30	U-1455	2021-03-03
N022483-001	10918635	2030-04-30	U-172	2021-03-03
N022483-001	11202752	2030-04-30	U-1455	2022-01-19
N022483-001	11202752	2030-04-30	U-172	2022-01-19
N022483-001	11850245	2030-04-30	U-1455	2024-01-12
N022483-001	11850245	2030-04-30	U-172	2024-01-12
N022483-002	11318130	2029-12-11	U-68	2022-05-20
N022483-002	8222270	2029-12-11	U-68	2012-07-18

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 3 · 82 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	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL		RLD, RS	2010-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`782e0a99824c…`

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	N022483-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022483-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022483-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022483-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022483-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022483-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022483-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022483-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022483-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022483-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022483-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022483-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022483-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022483-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022483-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022483-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022483-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022483-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022483-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 523 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`6a471c1ec25d…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imiquimod	IMIQUIMOD	Teva Pharmaceuticals USA, Inc.	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483 ndc (product): 0093-3133
Imiquimod	IMIQUIMOD	Oceanside Pharmacueticals	d86eeb0e-70e0-4c72-aaa3-37daa1d8611e	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483 ndc (product): 68682-272
Zyclara	IMIQUIMOD	Bausch Health US, LLC	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483 ndc (product): 99207-270 ndc (product): 99207-276 ndc (product): 99207-271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3133	Imiquimod	imiquimod	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3133	Imiquimod	imiquimod	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
63629-8818	Imiquimod	imiquimod	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8818	Imiquimod	imiquimod	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68682-272	Imiquimod	imiquimod	Oceanside Pharmacueticals	NDA	Current
68682-272	Imiquimod	imiquimod	Oceanside Pharmacueticals	NDA	Current
68682-272	Imiquimod	imiquimod	Oceanside Pharmacueticals	NDA	Current
68682-272	Imiquimod	imiquimod	Oceanside Pharmacueticals	NDA AUTHORIZED GENERIC	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-270	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-270	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-270	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-271	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-271	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-276	Zyclara	imiquimod	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current
99207-276	Zyclara	imiquimod	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79646	SUPPL	2024-09-18
79638	SUPPL	2024-09-17
29770	SUPPL	2012-02-17
17637	SUPPL	2012-02-17
7453	SUPPL	2011-10-03
38756	SUPPL	2011-09-30
7454	SUPPL	2011-07-19
17636	SUPPL	2011-07-18
17635	SUPPL	2011-03-28
7452	SUPPL	2011-03-25
17634	ORIG	2011-02-18
24319	ORIG	2011-02-17
22033	ORIG	2010-12-01
7451	ORIG	2010-03-29