Application 201506

Type: ANDA
Sponsor: JUBILANT GENERICS

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
A201506-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2012-04-03
A201506-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2012-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201506-001	AB
A201506-002	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	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`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	A201506-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201506-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201506-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201506-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201506-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201506-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201506-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201506-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201506-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201506-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201506-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201506-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201506-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201506-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201506-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201506-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201506-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201506-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	Direct Rx	cbd7bb49-7a9c-4383-a158-bfc307db0130	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506 ndc (product): 61919-066
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	2023-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506 ndc (product): 59746-325 ndc (product): 59746-324
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	efe37bd1-a236-43cc-828c-b57e8a704d67	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506 ndc (product): 63187-538

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-937	valacyclovir hydrochloride	valacyclovir hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
50436-3240	valacyclovir hydrochloride	valacyclovir hydrochloride	Unit Dose Services	ANDA	Current
50436-3250	valacyclovir hydrochloride	valacyclovir hydrochloride	Unit Dose Services	ANDA	Current
53002-0060	valacyclovir hydrochloride	valacyclovir hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0060	valacyclovir hydrochloride	valacyclovir hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0060	valacyclovir hydrochloride	valacyclovir hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-345	valacyclovir hydrochloride	valacyclovir hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-345	valacyclovir hydrochloride	valacyclovir hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59746-324	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-324	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-324	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-325	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-325	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-325	valacyclovir hydrochloride	valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
61919-066	Valacyclovir	Valacyclovir	Direct Rx	ANDA	Current
63187-538	valacyclovir hydrochloride	valacyclovir hydrochloride	Proficient Rx LP	ANDA	Current
63187-538	valacyclovir hydrochloride	valacyclovir hydrochloride	Proficient Rx LP	ANDA	Current
67296-1076	valacyclovir hydrochloride	valacyclovir hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1076	valacyclovir hydrochloride	valacyclovir hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68788-6379	valacyclovir hydrochloride	valacyclovir hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9984	valacyclovir hydrochloride	valacyclovir hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2346	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2928	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2928	valacyclovir hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
72189-037	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-037	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-037	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-037	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	DIRECT RX	ANDA	Current