Application 074885

Type: ANDA
Sponsor: EUROHLTH INTL SARL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	ACYCLOVIR SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	ACYCLOVIR SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1997-12-19
A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1997-12-19

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074885-001	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074885-002	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1997-12-19	`3a93d1ddd44b…`

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	Name fallback generic name: ACYCLOVIR SODIUM
Acyclovir Sodium	ACYCLOVIR SODIUM	Eugia US LLC	ae921e4e-b8ae-4a45-acc1-32e5e719812b	2023-07-05	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR SODIUM
Acyclovir Sodium	ACYCLOVIR SODIUM	AuroMedics Pharma LLC	d3ab226c-677d-4cb7-85cb-1c2e5012f40d	2017-09-18	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.