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001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A074556-001	ACYCLOVIR	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`84e616aacf4f…`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A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`caaa826d4ba7…`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 2 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Redpharm Drug	53cbca4d-3ddc-b11e-e063-6394a90a04fa	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	2b600b5d-ce91-461f-b9d1-75b969daf8e9	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Westminster Pharmaceuticals, LLC	f352a641-988e-4878-8016-2b69cd6ee548	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir suspension	ACYCLOVIR	Atlantic Biologicals Corp.	5105272f-cff8-8898-e063-6394a90aabb5	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Torrent Pharmaceuticals Limited	1c510390-fb00-4271-967d-0883a9d5e1fd	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Aryeh Pharma Corp	f60cc0c2-e0fe-406a-b5c0-90bc4b566bb3	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Proficient Rx LP	d4729677-164b-41b8-bbc4-4e47346b0f72	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	0990b625-5dfe-4810-b5b4-ac5948599e79	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Sportpharm LLC	c561bf77-5b26-4f23-9d49-9d964b48f772	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	c7317324-4654-4bcc-8edf-7b7cd8794d2e	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Cardinal Health 107, LLC	d8004652-86fe-4714-81d4-5e1dd2585bb4	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Northstar Rx LLC	6788f3c6-b79c-4f3f-9a73-10c8d3a38267	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	960e4ede-692e-4db2-a96e-dc6f4a6190ee	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	A-S Medication Solutions	a0ed999f-7366-42c3-a6f5-3c239215a99c	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2026-03-26	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