Application 206437

Type: ANDA
Sponsor: TOLMAR

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
A206437-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL			2017-07-31

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	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2017-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206437-001	ACYCLOVIR	5%	OINTMENT / TOPICAL		2017-07-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206437-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206437-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206437-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206437-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206437-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206437-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206437-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206437-001	AB	1	`ea99ee380514…`

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 3 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals, Inc.	b6d69697-12bb-4548-a6c3-2463cbf54f8f	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	2e6a3667-af06-40de-80c0-8c4346e0671f	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	American Health Packaging	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Camber Pharmaceuticals, Inc.	0910335b-6796-459f-b97e-d7ef5439a060	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Glenmark Pharmaceuticals Inc., USA	149f4418-7668-4d34-a6f9-69bf3a9c5049	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	ANI Pharmaceuticals, Inc.	8208711c-18ba-4615-b932-3c0bb7e6efae	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Actavis Pharma, Inc.	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	75334fc5-d236-401a-875c-f4f9c7749c1a	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	c11c1136-7421-48ff-86d2-39507e80a04c	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc.	b1033fda-8242-4006-b1cd-23474d70671f	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	AvPAK	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Avaclyr	ACYCLOVIR	Fera Pharmaceuticals, LLC	3ce26231-bc40-48b0-85e5-2e7622f334d7	2026-01-05	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Cadila Pharmaceuticals Limited	dbaf4bf5-57e3-4770-a9b2-d47649e54c1b	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	5dcfd21c-43f0-469c-be70-a4e74e6ccf88	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	f6f56143-ea74-af87-e053-6394a90ae346	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Northwind Health Company, LLC	ff9776b3-a248-e1ea-e053-6294a90aeb7b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	67e7b340-0635-2595-e053-2a91aa0ad266	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	8542495c-eef1-448b-abb5-83cb1ac589f7	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	677edfd5-2d04-b932-e053-2a91aa0a26b0	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Chartwell Governmental & Specialty RX, LLC.	2757bb30-3374-4e1b-b496-14874f7ec623	2025-12-23	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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63646-300	Acyclovir	Acyclovir	TOLMAR Inc.	ANDA	Current
63646-300	Acyclovir	Acyclovir	TOLMAR Inc.	ANDA	Current
63646-300	Acyclovir	Acyclovir	TOLMAR Inc.	ANDA	Current
68071-5157	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5157	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current