Application 204313

Type: ANDA
Sponsor: CADILA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	CAPSULE;ORAL	200MG	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
A204313-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204313-001	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 · 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	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204313-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	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 1 · 9 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	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Proficient Rx LP	d4729677-164b-41b8-bbc4-4e47346b0f72	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	0990b625-5dfe-4810-b5b4-ac5948599e79	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313 ndc (product): 70518-3436
acyclovir	ACYCLOVIR	A-S Medication Solutions	a0ed999f-7366-42c3-a6f5-3c239215a99c	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Northwind Health Company, LLC	ff9776b3-a248-e1ea-e053-6294a90aeb7b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	e580b7e9-9060-43f5-9b58-33998078d7e4	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313 ndc (product): 72578-002
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	395cd839-21e1-43e2-a8ce-078f07bc7668	2025-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313 ndc (product): 65841-829
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4	2025-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313 ndc (product): 68071-2526

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
60760-606	acyclovir	acyclovir	St. Mary's Medical Park Pharmacy	ANDA	Current
65841-829	acyclovir	acyclovir	Cadila Healthcare Limited	ANDA	Current
65841-829	acyclovir	acyclovir	Zydus Lifesciences Limited	ANDA	Current
65841-829	acyclovir	acyclovir	Cadila Healthcare Limited	ANDA	Current
68071-2526	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-668	acyclovir	acyclovir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-3436	acyclovir	acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-3436	acyclovir	acyclovir	REMEDYREPACK INC.	ANDA	Current
72578-002	acyclovir	acyclovir	Viona Pharmaceuticals Inc	ANDA	Current
72578-002	acyclovir	acyclovir	Viona Pharmaceuticals Inc	ANDA	Current