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001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A074556-001	ACYCLOVIR	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`84e616aacf4f…`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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`caaa826d4ba7…`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 6 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	6ea3e3f6-132d-4b15-ac58-336de05201a7	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	290af212-7332-4914-9ef0-65760478fb32	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	0d99ba77-c3c5-1fd0-e063-6294a90a6f2a	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e0f17e6f-63c7-4828-8585-91fc582df30b	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8c5d1f30-2d31-417d-860b-7228b7baaa64	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	af9d41f5-4658-4487-8811-32a1f8af9384	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	89583890-186b-4a7a-8741-41f6c5f0a99d	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	01ae85df-d1a0-44f7-b4c0-0ac74d2216d4	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	a68e610a-841c-4b69-9233-673d060561e8	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	37499620-6a17-40f1-b0db-dd79320ea21d	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c46d5033-b1b2-e213-e053-2995a90ae6a3	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals, Inc.	40e5cc54-ed74-3369-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	bb956f2b-627a-49bd-b258-4aac21d64b9a	2024-08-14		Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	fdf6b492-a76e-4cea-89a1-a5b19c7938ff	2024-08-14		Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	a7fd298b-3914-4316-8484-2d3ae188221a	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	ada4004a-c10a-6190-e053-2a95a90a5e67	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b1b999a9-11cc-d6e5-e053-2995a90a5478	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b2ae0432-bd2a-1480-e053-2a95a90a6fc8	2024-07-17	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