Application 078518

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	No	No
002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 1GM BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078518-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2010-05-24
A078518-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2010-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078518-001	AB
A078518-002	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 3 · 82 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	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078518-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078518-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078518-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078518-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078518-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078518-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078518-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078518-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078518-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078518-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078518-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078518-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078518-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078518-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078518-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078518-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078518-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078518-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078518-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078518-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078518-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078518-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078518-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078518-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078518-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078518-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078518-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078518-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078518-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078518-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078518-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078518-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078518-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078518-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078518-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078518-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078518-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078518-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078518-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078518-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078518-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078518-002	AB	1	`782e0a99824c…`

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
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	1ecd2332-4c60-46c1-a175-774926ffc6c6	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518 ndc (product): 70518-0541
Valacyclovir Hydrochloride	VALACYCLOVIR	Northwind Health Company, LLC	1b53c6bb-0e8c-f49a-e063-6294a90a0f5a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518
Valacyclovir Hydrochloride	VALACYCLOVIR	Northwind Health Company, LLC	5036e5f8-e659-6010-e063-6294a90af947	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	c28c069f-3b51-4474-aa38-1aed6b7b8678	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518 ndc (product): 71335-1341
Valacyclovir Hydrochloride	VALACYCLOVIR	Safecor Health LLC	021ab9d0-7b75-40cf-afde-446942d64388	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518
Valacyclovir Hydrochloride	VALACYCLOVIR	Mylan Pharmaceuticals Inc.	56bf715d-8280-4557-9f98-9693932199e5	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518 ndc (product): 0378-4276 ndc (product): 0378-4275
Valacyclovir Hydrochloride	VALACYCLOVIR	Redpharm Drug	301edb6c-9ce0-f9fa-e063-6294a90a2909	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518
Valacyclovir Hydrochloride	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	9eff97fa-095c-483c-a4eb-e46e5fef7785	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Mylan Institutional Inc.	2f0ecd75-e4b4-4493-b7a4-1666fc555c70	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078518 application number: ANDA078518 ndc (product): 51079-093

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
70518-0541	Valacyclovir Hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0541	Valacyclovir Hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3451	Valacyclovir Hydrochloride	valacyclovir	REMEDYREPACK INC.	ANDA	Current
70518-3451	Valacyclovir Hydrochloride	valacyclovir	REMEDYREPACK INC.	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1485	Valacyclovir Hydrochloride	valacyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1485	Valacyclovir Hydrochloride	valacyclovir	Bryant Ranch Prepack	ANDA	Current