Application 076588

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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 42.

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
A076588-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2007-01-31
A076588-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2007-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076588-001	AB
A076588-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076588-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076588-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076588-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	Golden State Medical Supply, Inc.	e3b4757b-d97b-6714-e053-2995a90a64eb	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588 ndc (product): 51407-108 ndc (product): 51407-107
Valacyclovir	VALACYCLOVIR	SUN PHARMACEUTICAL INDUSTRIES, INC.	26634bf1-c6d8-4d48-9a4e-845c47df07f8	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588 ndc (product): 63304-905 ndc (product): 63304-904

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-200	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51407-107	Valacyclovir	Valacyclovir	Golden State Medical Supply, Inc.	ANDA	Current
51407-108	Valacyclovir	Valacyclovir	Golden State Medical Supply, Inc.	ANDA	Current
51660-904	VALACYCLOVIR	VALACYCLOVIR HYDROCHLORIDE	Ohm Laboratories Inc.	ANDA	Current
51660-905	VALACYCLOVIR	VALACYCLOVIR HYDROCHLORIDE	Ohm Laboratories Inc.	ANDA	Current
63304-904	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-904	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-904	Valacyclovir	Valacyclovir	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-904	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-905	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-905	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-905	Valacyclovir	Valacyclovir	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-905	Valacyclovir	Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
68071-3276	Valacyclovir	Valacyclovir	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-0323	Valacyclovir	Valacyclovir	REMEDYREPACK INC.	ANDA	Current