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001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A074556-001	ACYCLOVIR	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`84e616aacf4f…`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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`caaa826d4ba7…`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 5 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Sun Pharmaceutical Industries, Inc.	962b2e1a-ba9d-4b39-b6d1-203947166482	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Sun Pharmaceutical Industries, Inc.	6e3b04a8-47a4-425e-931e-9a4fa260b303	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	d0908b3c-f5dd-4113-9080-bb01abe13c9c	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Direct_Rx	387d33ed-45e5-42d6-e063-6294a90afbb7	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	067109d0-2539-42b6-9e95-102b58ca54dc	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Alembic Pharmaceuticals Inc.	5adf2205-5493-4e7a-bf50-01f4eb661dd8	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f87c2c1e-568f-49e1-979e-fce80086fe08	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8d171c3d-de39-4f82-bacb-3e8d71b16540	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Coupler LLC	2cdbea8d-29df-0045-e063-6294a90a9506	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	713960c2-8278-4778-b781-08ec89a9cfce	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4	2025-01-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	116f4f0d-66c5-49dd-e063-6394a90ab2b5	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Advanced Rx Pharmacy of Tennessee, LLC	f4c5779d-e4bf-4f2b-e053-2995a90a9187	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	a2966b6d-c6c0-4afd-8eda-045df497cb9d	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Fresenius Kabi USA, LLC	b1bb347d-74f4-4976-8450-a375a271718f	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f3cbd634-77c8-3306-bdbd-a4598b20603e	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Amneal Pharmaceuticals LLC	269e2203-347d-40dc-b794-11cf34690f27	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	b96e44ca-aa54-4a64-89f4-fb5a5932ceae	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	c0c29e0f-b6e2-49df-88d1-95b7b625d356	2024-10-14	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