Application 074980

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	400MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074980-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL			1998-09-30
A074980-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL			1998-09-30

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`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 7 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b455053f-3deb-bd76-e053-2a95a90a9869	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	638803d2-a172-486d-e053-2991aa0ab074	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Fresenius Kabi USA, LLC	badf347b-eeee-4239-9c74-966f262925aa	2024-06-30	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Fresenius Kabi USA, LLC	cb64dfab-52ee-4312-bc9c-c3d04efe9109	2024-06-27	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	968800dc-9456-a45f-e053-2995a90aa15e	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	67a7ab8b-4b85-4f7b-8ae0-3dcdc273ed69	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	83e82707-85b6-2fea-e053-2991aa0a99ef	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	bf1b4142-c5f3-4147-8224-bf6344566694	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	331fe0bd-6bb2-4337-8faa-d0c82ff54dc7	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Hikma Pharmaceuticals USA Inc.	babdbce2-5cbd-4943-bc38-9ebdd696a77a	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	c0e41bf9-e141-404e-9952-aeeb705958b4	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: ACYCLOVIR generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e73ae5c8-7a77-4330-817d-482d1de4e994	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Padagis Israel Pharmaceuticals Ltd	63fadf54-e8a3-4512-8a05-d64b998f5a08	2024-03-31	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Slate Run Pharmaceuticals, LLC	889bccd1-3793-40ce-bca2-c8c9cf6b7488	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6e813b35-4ead-42d6-bc51-9d7caf1db1ef	2024-02-13	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	A-S Medication Solutions	f3e6b1ad-810b-4f53-b92a-b28fc2111f3f	2024-01-25	Warnings, Adverse reactions	Name fallback brand name: acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	a4c15f29-313f-49ca-acfa-c0e6910f64fb	2024-01-25	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e2b2c88a-84d2-42e6-ad18-819f7e78dbd6	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	d04c696f-c072-46f7-9a92-9cbb476c827b	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Acyclovir generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Proficient Rx LP	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2024-01-01	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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-039	Acyclovir	acyclovir	Blenheim Pharmacal, Inc.	ANDA	Current
21695-010	Acyclovir	acyclovir	Rebel Distributors Corp	ANDA	Current
21695-011	Acyclovir	acyclovir	Rebel Distributors Corp	NDA AUTHORIZED GENERIC	Current
63304-504	Acyclovir	acyclovir	Ranbaxy Laboratories Ltd.	ANDA	Current
63304-505	Acyclovir	acyclovir	Ranbaxy Laboratories Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30727	ORIG	1998-09-30