Application 205591

Type: ANDA
Sponsor: ACP NIMBLE

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 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
A205591-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL			2017-11-13

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	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205591-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-11-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205591-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205591-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205591-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205591-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205591-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205591-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205591-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205591-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205591-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205591-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205591-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205591-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205591-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205591-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205591-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205591-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205591-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205591-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205591-001	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 9 · 178 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	86c43bdf-c5bf-47cd-8dfd-811263825878	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	6d0e492e-5359-49e8-812d-8c8e2e5d42f8	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	736679be-469e-4bdb-8e15-b10751c3dd60	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	38547daa-7d2f-4a7b-84d3-6e164984f958	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Major Pharmaceuticals	9b254eed-8ea1-469b-bf27-f5670cd99e8d	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	ATLANTIC BIOLOGICALS CORP.	da5a809c-6ddc-4609-9a34-ccb3d2d43976	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	85332671-0e3a-4445-a337-e1266886b9cf	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	499c6a98-0614-4ded-8526-909942bae8a4	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	37a51d9c-1f39-4065-8c7d-6528ac6de91c	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Alembic Pharmaceuticals Inc.	878615c2-09ea-44ce-8c30-7a7f16acb20c	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	db35fce0-d7a3-4589-ba60-d78cdb1119cb	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Redpharm Drug	53cbca4d-3ddc-b11e-e063-6394a90a04fa	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	2b600b5d-ce91-461f-b9d1-75b969daf8e9	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Cardinal Health 107, LLC	4cc7d67f-35fa-4238-a581-4810645083cf	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Westminster Pharmaceuticals, LLC	f352a641-988e-4878-8016-2b69cd6ee548	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Major Pharmaceuticals	864d96b9-e2de-45a8-850b-6f7b72ceefe1	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0630	Acyclovir	Acyclovir	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0630	Acyclovir	Acyclovir	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0630	Acyclovir	Acyclovir	G&W Laboratories, Inc.	ANDA	Current
0713-0630	Acyclovir	Acyclovir	Cosette Pharmaceuticals, Inc.	ANDA	Current
35573-403	Acyclovir	Acyclovir	Burel Pharmaceuticals, LLC	ANDA	Current
35573-403	Acyclovir	Acyclovir	Burel Pharmaceuticals, LLC	ANDA	Current