Application 077655

Type: ANDA
Sponsor: TEVA PHARMS

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 43.

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
A077655-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL			2010-05-24
A077655-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL			2010-05-24

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 · 86 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
2026-09-14 22:38:34	2026-08	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077655-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077655-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077655-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077655-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077655-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077655-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077655-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077655-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077655-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077655-002	AB	1	`ea99ee380514…`

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 2 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	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
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae8d15a4-1ed5-4e3c-9672-0f4735322a1c	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e300970d-1145-4460-a8c8-f6e1654c2c3d	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR	Mylan Pharmaceuticals Inc.	56bf715d-8280-4557-9f98-9693932199e5	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	458bb24a-4f97-4003-93cb-356906a432c9	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f32d5f04-4198-82a5-e053-2995a90a1841	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f98aea50-e4d9-c0cc-e053-6294a90a811c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	fb875f07-e9a0-48eb-a8b0-16ea7bbae9ab	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir	VALACYCLOVIR	Yiling Pharmaceutical, Inc.	f3ee4017-a4fc-475d-a49b-b39168ec5966	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR	Redpharm Drug	301edb6c-9ce0-f9fa-e063-6294a90a2909	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Aurobindo Pharma Limited	f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
VALTREX	VALACYCLOVIR HYDROCHLORIDE	GlaxoSmithKline LLC	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	AvPAK	7f5fc62f-d043-db36-ce92-7adc4f7a79a5	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	9eff97fa-095c-483c-a4eb-e46e5fef7785	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	82ddec27-79ac-40f4-afde-707f3940f893	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Mylan Institutional Inc.	2f0ecd75-e4b4-4493-b7a4-1666fc555c70	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmacuticals,Inc.	552b806d-97d2-364d-e054-00144ff8d46c	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	802308ed-8c26-fed5-e053-2a91aa0a42b0	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	82bac944-417a-0af7-e053-2a91aa0a8674	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8422aeeb-0c3b-478d-82fb-ca051809db01	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7258	Valacyclovir	Valacyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7259	Valacyclovir	Valacyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7259	Valacyclovir	Valacyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7259	Valacyclovir	Valacyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
53808-0635	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
66116-516	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	MedVantx, Inc.	ANDA	Current
68071-3372	Valacyclovir	Valacyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current