Application 078837

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIQUIMOD	IMIQUIMOD	CREAM;TOPICAL	5%	No	No

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
A078837-001	IMIQUIMOD	IMIQUIMOD	5%	CREAM / TOPICAL	AB		2010-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078837-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078837-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078837-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078837-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078837-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078837-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078837-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078837-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078837-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078837-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078837-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078837-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078837-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078837-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078837-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078837-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078837-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078837-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078837-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078837-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078837-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078837-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078837-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078837-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078837-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078837-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078837-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078837-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078837-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078837-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078837-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078837-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078837-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078837-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078837-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078837-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078837-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078837-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078837-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078837-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078837-001	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	9291e5cd-b83d-4b43-88f5-30cac6cef5ff	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	f8db59e2-8052-413b-9f9f-07cd9eea07ec	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	47d3045f-a145-4095-bb8a-c67ba1ff3bda	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Padagis Israel Pharmaceuticals Ltd	1505cf54-37da-4b2b-9812-6ffd6a01a7c7	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837 ndc (product): 45802-368
IMIQUIMOD	IMIQUIMOD	DIRECT RX	a18a3f7e-7254-56c0-e053-2a95a90a7036	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837 ndc (product): 72189-084

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
45802-368	Imiquimod	Imiquimod	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-368	Imiquimod	Imiquimod	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-368	Imiquimod	Imiquimod	Perrigo New York Inc	ANDA	Current
72189-084	IMIQUIMOD	IMIQUIMOD	DIRECT RX	ANDA	Current