Application 075090

Type: ANDA
Sponsor: KENTON

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
A075090-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		1999-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075090-001	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	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`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	A075090-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Florida Pharmaceutical Products, LLC	3df7fa38-a869-45fb-98a3-81c5a2527d62	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f87c2c1e-568f-49e1-979e-fce80086fe08	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090 ndc (product): 71335-0280
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6e813b35-4ead-42d6-bc51-9d7caf1db1ef	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090 ndc (product): 50090-5610
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e8433261-07f1-448b-aaf4-631414598c08	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Quinn Pharmaceuticals	9ad711e4-003d-4b58-8177-32928bc42aa9	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090 ndc (product): 69076-146
Acyclovir	ACYCLOVIR	Proficient Rx LP	6714cfd9-97d3-4290-b618-54594d89cf4e	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090 ndc (product): 71205-209

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-146	Acyclovir	Acyclovir	Heritage Pharmaceuticals, Inc.	ANDA	Current
43063-701	Acyclovir	Acyclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0596	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-0596	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-0596	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-0596	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-2381	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-5610	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50268-060	Acyclovir	Acyclovir	AvPAK	ANDA	Current
55154-4329	Acyclovir	Acyclovir	Cardinal Health	ANDA	Current
55700-651	Acyclovir	Acyclovir	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-651	Acyclovir	Acyclovir	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61442-111	Acyclovir	Acyclovir	Carlsbad Technology, Inc.	ANDA	Current
63187-182	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
63187-182	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
67296-0656	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-0656	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1543	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1543	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1543	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
68788-9690	Acyclovir	Acyclovir	Preferred Pharmaceuticals, Inc.	ANDA	Current
69076-146	Acyclovir	Acyclovir	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-146	ACYCLOVIR	ACYCLOVIR	Quinn Pharmaceuticals	ANDA	Current
69076-146	Acyclovir	Acyclovir	Quinn Pharmaceuticals	ANDA	Current
69076-146	Acyclovir	Acyclovir	Quinn Pharmaceuticals	ANDA	Current
70518-0131	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1076	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1076	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70934-800	Acyclovir	Acyclovir	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-800	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-800	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-209	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71205-209	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71205-209	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71335-0280	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-0280	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-0280	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-0280	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42932	ORIG	2007-04-09
30752	ORIG	1999-01-26