Application 090370

Type: ANDA
Sponsor: WATSON LABS 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
A090370-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL			2011-03-16
A090370-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL			2011-03-16

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090370-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2011-03-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090370-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	2011-03-16	`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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	de96c14b-cd74-46dd-bcce-d1fa640a6037	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Redpharm Drug	57e5cc11-f3cb-6266-e063-6394a90afc47	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
VALTREX	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	1ecd2332-4c60-46c1-a175-774926ffc6c6	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR	Northwind Health Company, LLC	1b53c6bb-0e8c-f49a-e063-6294a90a0f5a	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR	Northwind Health Company, LLC	5036e5f8-e659-6010-e063-6294a90af947	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	a56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	c28c069f-3b51-4474-aa38-1aed6b7b8678	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	275c0198-10a5-139e-e063-6394a90a72be	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	93dccd99-d28b-4c47-872c-c3c0001b8a7f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR	Safecor Health LLC	021ab9d0-7b75-40cf-afde-446942d64388	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a888812-2867-4dd3-b56e-2d98da837d1f	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NorthStar Rx LLC	4acf51de-26f7-42b2-8acc-61b800627ef3	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	7681a6f4-a6e7-4277-adbd-38837d5ead6b	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	8c0be4f6-2d11-41d4-8f57-4f8db9da60b2	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Major Pharmaceuticals	fd982aee-d503-47b3-8d3d-42e9a8690457	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	87ec59e3-c06a-4ca7-bc65-5b251263ab3b	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	df34e11d-5f2c-4755-b84b-b95d1d7b73f0	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Rising Pharma Holdings, Inc.	8d1645c0-fd03-4992-9372-98026a26b3af	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-534	Valacyclovir hydrochloride	Valacyclovir hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45963-558	Valacyclovir hydrochloride	Valacyclovir hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-559	Valacyclovir hydrochloride	Valacyclovir hydrochloride	Actavis Pharma, Inc.	ANDA	Current
51655-955	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
63187-311	Valacyclovir hydrochloride	Valacyclovir hydrochloride	Proficient Rx LP	ANDA	Current
68071-4040	Valacyclovir hydrochloride	Valacyclovir hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current