Application 078548

Type: ANDA
Sponsor: FOUGERA PHARMS

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
A078548-001	IMIQUIMOD	IMIQUIMOD	5%	CREAM / TOPICAL	AB		2010-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078548-001	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	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078548-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-02-25	`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	A078548-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078548-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078548-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078548-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078548-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078548-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078548-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078548-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078548-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078548-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078548-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078548-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078548-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078548-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078548-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078548-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078548-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078548-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078548-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078548-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078548-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078548-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078548-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078548-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078548-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078548-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078548-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078548-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078548-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078548-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078548-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078548-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078548-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078548-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078548-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078548-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078548-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078548-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078548-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078548-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	9291e5cd-b83d-4b43-88f5-30cac6cef5ff	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	f8db59e2-8052-413b-9f9f-07cd9eea07ec	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Sun Pharmaceutical Industries, Inc.	59af8153-4cf8-4f22-9000-f239798d52d1	2025-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	47d3045f-a145-4095-bb8a-c67ba1ff3bda	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Teva Pharmaceuticals USA, Inc.	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Oceanside Pharmacueticals	d86eeb0e-70e0-4c72-aaa3-37daa1d8611e	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Imiquimod 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 brand name: Imiquimod generic name: IMIQUIMOD
Imiquimod	IMIQUIMOD	Glenmark Pharmaceuticals Inc., USA	663e39a9-a29e-473f-89ec-4c7c6bc27b8a	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Imiquimod generic name: IMIQUIMOD
IMIQUIMOD	IMIQUIMOD	DIRECT RX	a18a3f7e-7254-56c0-e053-2a95a90a7036	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: IMIQUIMOD generic name: IMIQUIMOD

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0432	imiquimod	imiquimod	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22624	ORIG	2012-11-16
31371	ORIG	2010-03-03