Application 201445

Type: ANDA
Sponsor: CADILA PHARMS LTD

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 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
A201445-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2014-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201445-001	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	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`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	A201445-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201445-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201445-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201445-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201445-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201445-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201445-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201445-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201445-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201445-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201445-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201445-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201445-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201445-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201445-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201445-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201445-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201445-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201445-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201445-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201445-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201445-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201445-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201445-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201445-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201445-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201445-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201445-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201445-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201445-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201445-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201445-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201445-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201445-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201445-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201445-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201445-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201445-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201445-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201445-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	c7317324-4654-4bcc-8edf-7b7cd8794d2e	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201445 application number: ANDA201445 ndc (product): 72241-028
Acyclovir	ACYCLOVIR	Cadila Pharmaceuticals Limited	dbaf4bf5-57e3-4770-a9b2-d47649e54c1b	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201445 application number: ANDA201445 ndc (product): 71209-004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5739	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
67296-1723	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1723	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
68071-2235	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2235	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4528	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4528	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4528	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0806	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-0806	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
71209-004	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-004	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-004	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71209-004	Acyclovir	Acyclovir	Cadila Pharmaceuticals Limited	ANDA	Current
71335-1013	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1013	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1013	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
72241-028	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
72241-028	Acyclovir	Acyclovir	Modavar Pharmaceuticals LLC	ANDA	Current
75834-124	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-124	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-124	Acyclovir	Acyclovir	Nivagen Pharmaceuticals, Inc.	ANDA	Current