Application 074556

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	400MG	No	No
003	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074556-001	ACYCLOVIR	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22
A074556-002	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22
A074556-003	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074556-002	AB
A074556-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074556-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074556-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074556-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074556-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074556-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074556-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074556-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074556-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074556-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074556-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074556-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074556-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074556-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074556-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074556-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074556-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074556-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074556-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074556-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074556-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074556-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074556-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074556-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074556-003	AB	1	`74a2ff9319b5…`

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 8 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	A-S Medication Solutions	e4f91376-9e18-41a4-aa5e-adcea0c625d9	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bionpharma Inc.	6f1db9f0-9b41-4fb7-8798-44fdc2c128df	2023-12-03	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir suspension	ACYCLOVIR	Novadoz Pharmaceuticals LLC	3efa1e5e-5a14-4724-a2ca-25702f10faed	2023-11-03	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	A-S Medication Solutions	942632d8-08cd-4003-aec0-1c6d5c09bc15	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	SQUARE PHARMACEUTICALS LIMITED	b24201ea-aeae-4de1-b01b-eee89068e786	2023-07-02	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e8433261-07f1-448b-aaf4-631414598c08	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	A-S Medication Solutions	c40a57b9-4cf1-4a69-abf3-eb99a7fcda00	2023-04-16	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	34a38cdf-04e8-4006-a9f5-4a0831117d61	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	8de9c4f3-b800-4419-a063-8b62a0cba0fa	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Quinn Pharmaceuticals	9ad711e4-003d-4b58-8177-32928bc42aa9	2022-12-20	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	383b930b-6e9c-4ac9-a078-baac6276f340	2022-10-17		Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PharmPak, Inc.	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2022-10-09	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PharmPak, Inc.	8fb01f23-e2bd-6850-e053-2995a90a7cc5	2022-10-09	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	12df1991-fb1c-45df-acf3-706b1e8ecfc3	2022-10-05	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Camber Pharmaceuticals, Inc.	2ca1395f-96b4-4543-8eed-bd07c62bbc7c	2022-09-12	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	e8056ec6-d2dc-48af-8550-82726af1c5c5	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	9e5b3a11-9c4b-4998-8a18-3046af1314ab	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	33630a35-346e-43b6-9286-89e28ac0094a	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	c55bde35-a202-4c25-b545-e5d5e95c1175	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	32aa3f42-23a1-4867-8228-e6e76cf9f135	2022-02-01	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8943	Acyclovir	Acyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8947	Acyclovir	Acyclovir	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-102	Acyclovir	Acyclovir	Blenheim Pharmacal, Inc.	ANDA	Current
10544-103	Acyclovir	Acyclovir	Blenheim Pharmacal, Inc.	ANDA	Current
12634-520	Acyclovir	Acyclovir	Apotheca Inc.	ANDA	Current
33261-227	Acyclovir	Acyclovir	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-491	Acyclovir	Acyclovir	Aidarex Pharmaceuticals LLC	ANDA	Current
42708-073	Acyclovir	Acyclovir	QPharma Inc	ANDA	Current
42708-073	Acyclovir	Acyclovir	QPharma Inc	ANDA	Current
52959-544	Acyclovir	Acyclovir	H.J. Harkins Company Inc.	ANDA	Current
53808-0821	Acyclovir	Acyclovir	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0894	Acyclovir	Acyclovir	State of Florida DOH Central Pharmacy	ANDA	Current
55289-462	Acyclovir	Acyclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-629	Acyclovir	Acyclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
58118-8943	Acyclovir	Acyclovir	Clinical Solutions Wholesale	ANDA	Current
58118-8943	Acyclovir	Acyclovir	Clinical Solutions Wholesale	ANDA	Current
63629-1677	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-6349	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-6349	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-6376	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-6376	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
66116-414	Acyclovir	Acyclovir	MedVantx, Inc.	ANDA	Current
67296-1054	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1054	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1219	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
67296-1219	Acyclovir	Acyclovir	RedPharm Drug, Inc.	ANDA	Current
70518-0065	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-0065	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-0065	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-0798	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-0798	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current