Application 218111

Type: ANDA
Sponsor: SLATE RUN PHARMA

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
A218111-001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP		2024-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218111-001	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.

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	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218111-001	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2024-01-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218111-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218111-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218111-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218111-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218111-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218111-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218111-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218111-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218111-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218111-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218111-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218111-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218111-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218111-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218111-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218111-001	AP	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218111-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	Slate Run Pharmaceuticals, LLC	889bccd1-3793-40ce-bca2-c8c9cf6b7488	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218111 application number: ANDA218111