Application 206535

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	Yes
002	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206535-001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206535-001	AP

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206535-001	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206535-002	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	2018-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206535-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2018-08-31	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206535-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206535-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206535-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206535-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206535-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206535-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206535-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206535-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206535-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206535-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206535-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206535-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206535-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206535-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206535-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206535-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206535-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206535-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206535-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206535-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206535-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206535-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206535-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206535-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206535-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206535-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206535-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206535-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206535-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206535-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206535-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206535-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206535-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206535-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206535-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206535-001	AP	1	`a50c72e98297…`

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
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	383b930b-6e9c-4ac9-a078-baac6276f340	2022-10-17		Exact identifier application applno (ANDA): 206535 application number: ANDA206535 ndc (product): 70771-1383 ndc (product): 70771-1384
acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	69a98000-adef-4323-89a7-09e035a257d4	2021-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206535 application number: ANDA206535 ndc (product): 68382-049 ndc (product): 68382-048

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-048	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-048	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-048	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-048	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-048	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-049	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-049	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-049	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-049	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-049	acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1383	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current
70771-1384	acyclovir	ACYCLOVIR	Cadila Healthcare Limited	ANDA	Current