Application 203701

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203701-001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2013-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203701-001	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 · 41 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	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203701-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2013-10-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203701-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203701-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203701-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203701-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203701-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203701-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203701-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203701-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203701-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203701-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203701-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203701-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203701-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203701-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203701-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203701-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203701-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203701-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203701-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203701-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203701-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203701-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203701-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203701-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203701-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203701-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203701-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203701-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203701-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203701-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203701-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203701-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203701-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203701-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203701-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203701-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203701-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203701-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203701-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203701-001	AP	1	`cb3db0bc1861…`

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
Acyclovir Sodium	ACYCLOVIR SODIUM	ProPharma Distribution	23a7cf9e-f21b-06c2-e063-6394a90aa623	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203701 application number: ANDA203701
Acyclovir Sodium	ACYCLOVIR SODIUM	Eugia US LLC	ae921e4e-b8ae-4a45-acc1-32e5e719812b	2023-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203701 application number: ANDA203701 ndc (product): 55150-154 ndc (product): 55150-155
Acyclovir Sodium	ACYCLOVIR SODIUM	AuroMedics Pharma LLC	d3ab226c-677d-4cb7-85cb-1c2e5012f40d	2017-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203701 application number: ANDA203701 ndc (product): 55150-154 ndc (product): 55150-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-154	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-154	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-154	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-155	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-155	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-155	Acyclovir Sodium	Acyclovir Sodium	AuroMedics Pharma LLC	ANDA	Current