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 5 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Sun Pharmaceutical Industries, Inc.	962b2e1a-ba9d-4b39-b6d1-203947166482	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Sun Pharmaceutical Industries, Inc.	6e3b04a8-47a4-425e-931e-9a4fa260b303	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	d0908b3c-f5dd-4113-9080-bb01abe13c9c	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Direct_Rx	387d33ed-45e5-42d6-e063-6294a90afbb7	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	067109d0-2539-42b6-9e95-102b58ca54dc	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Alembic Pharmaceuticals Inc.	5adf2205-5493-4e7a-bf50-01f4eb661dd8	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f87c2c1e-568f-49e1-979e-fce80086fe08	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8d171c3d-de39-4f82-bacb-3e8d71b16540	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Coupler LLC	2cdbea8d-29df-0045-e063-6294a90a9506	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	713960c2-8278-4778-b781-08ec89a9cfce	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4	2025-01-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	116f4f0d-66c5-49dd-e063-6394a90ab2b5	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Advanced Rx Pharmacy of Tennessee, LLC	f4c5779d-e4bf-4f2b-e053-2995a90a9187	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	a2966b6d-c6c0-4afd-8eda-045df497cb9d	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Fresenius Kabi USA, LLC	b1bb347d-74f4-4976-8450-a375a271718f	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f3cbd634-77c8-3306-bdbd-a4598b20603e	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Amneal Pharmaceuticals LLC	269e2203-347d-40dc-b794-11cf34690f27	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	b96e44ca-aa54-4a64-89f4-fb5a5932ceae	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	c0c29e0f-b6e2-49df-88d1-95b7b625d356	2024-10-14	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