Application 205974

Type: ANDA
Sponsor: CADILA

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 42.

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
A205974-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB		2019-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205974-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205974-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205974-001	AB	1	`e64feba35796…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	Sportpharm LLC	c561bf77-5b26-4f23-9d49-9d964b48f772	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974
acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	c11c1136-7421-48ff-86d2-39507e80a04c	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974 ndc (product): 68788-8247
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	fdf6b492-a76e-4cea-89a1-a5b19c7938ff	2024-08-14		Exact identifier application applno (ANDA): 205974 application number: ANDA205974 ndc (product): 70771-1371
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	12df1991-fb1c-45df-acf3-706b1e8ecfc3	2022-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974 ndc (product): 72578-082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-2488	acyclovir	acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-992	acyclovir	acyclovir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-992	acyclovir	acyclovir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-992	acyclovir	acyclovir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-8247	acyclovir	acyclovir	Preferred Pharmaceuticals Inc	ANDA	Current
70771-1371	acyclovir	acyclovir	Zydus Lifesciences Limited	ANDA	Current
70771-1371	acyclovir	acyclovir	Cadila Healthcare Limited	ANDA	Current
70771-1371	acyclovir	acyclovir	Cadila Healthcare Limited	ANDA	Current
72578-082	acyclovir	acyclovir	Viona Pharmaceuticals Inc	ANDA	Current
72578-082	acyclovir	acyclovir	Viona Pharmaceuticals Inc	ANDA	Current