Application 206633

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206633-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB		2016-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206633-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206633-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2016-05-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206633-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206633-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206633-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206633-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206633-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206633-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206633-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206633-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206633-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206633-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206633-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206633-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206633-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206633-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206633-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206633-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206633-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206633-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206633-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206633-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206633-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206633-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206633-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206633-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206633-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206633-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206633-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206633-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206633-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206633-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206633-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206633-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206633-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206633-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206633-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206633-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206633-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206633-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206633-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206633-001	AB	1	`f41ea6bd6efb…`

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 9 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	69a98000-adef-4323-89a7-09e035a257d4	2021-11-29	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Solco Healthcare US, LLC	a1d7b8ec-309d-447e-ae05-b9e89cc29948	2021-11-15	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Macleods Pharmaceuticals Limited	d42fce5a-9ea3-4058-a3ba-4c18a6024160	2021-08-24	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Amneal Pharmaceuticals LLC	9167ea4a-959d-402c-96b4-619395821c01	2021-07-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Zovirax	ACYCLOVIR	Bausch Health US, LLC	125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2	2021-02-01	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Proficient Rx LP	3da54b2d-a206-4ff5-8cc2-90762c4fd70d	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Proficient Rx LP	4c5a75fa-73db-4f48-895f-de1635d33f49	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	2020-12-01	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	ACTAVIS PHARMA, INC.	b360a808-a24d-4f3c-89a7-9941422d17d6	2020-10-31	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Zovirax	ACYCLOVIR	Bausch Health US, LLC	50278e0e-da1e-45ee-9fcb-672b2a219911	2020-10-31	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Asclemed USA, Inc.	e186fdc9-b60e-4280-8d60-36cae9f2838f	2020-09-25	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Proficient Rx LP	51052f0e-1a07-405a-a962-981ce9439e02	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Xiromed, LLC	3e222423-3bf2-6584-6d54-447b1b26dc42	2020-01-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	6714cfd9-97d3-4290-b618-54594d89cf4e	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0825	acyclovir	acyclovir	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0825	acyclovir	acyclovir	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0825	acyclovir	acyclovir	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current