Application 077478

Type: ANDA
Sponsor: SANDOZ

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
A077478-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL			2010-05-24
A077478-002	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	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-001	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	A077478-002	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	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-001	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	A077478-002	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	A077478-001	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	A077478-002	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	A077478-001	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	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077478-002	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	A077478-001	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	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077478-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077478-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077478-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077478-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077478-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077478-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077478-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077478-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077478-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077478-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077478-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077478-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077478-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077478-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077478-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077478-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077478-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077478-002	AB	1	`1c564ffb4f44…`

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 3 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	American Health Packaging	23fb4162-2310-486c-ba9f-f7c94b793e56	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8022eb52-da04-eb0a-e053-2a91aa0a6f87	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	e005139e-6f76-9b2f-e053-2a95a90ab0fb	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	2024-08-28	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Asclemed USA, Inc.	1864bf8b-07a2-4b82-8592-bf8ad6f9f8f9	2024-07-11	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	883f643b-27f6-5a3e-e053-2995a90a8ff1	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	2023-08-30	Warnings, Adverse reactions	Name fallback brand name: valacyclovir hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	c6328ed5-a3d3-4948-94be-b226271d0311	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	268af320-810a-48de-9a08-9850be2878e3	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	c33a2a36-16d3-4a35-e053-2995a90af240	2021-07-17	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Asclemed USA, Inc.	b99b8309-dd80-422a-9b17-f20386dc4d8d	2020-10-24	Warnings, Adverse reactions	Name fallback brand name: Valacyclovir Hydrochloride generic name: VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	efe37bd1-a236-43cc-828c-b57e8a704d67	2020-01-01	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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5208	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc	ANDA	Current
0781-5208	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
0781-5208	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
0781-5208	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
0781-5209	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc	ANDA	Current
0781-5209	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
0781-5209	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
0781-5209	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Sandoz Inc.	ANDA	Current
61919-919	Valacyclovir	Valacyclovir	Direct Rx	ANDA	Current
68788-9432	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2329	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	REMEDYREPACK INC.	ANDA	Current
75921-208	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	Life Line Home Care Services, Inc.	ANDA	Current