Application 210401

Type: ANDA
Sponsor: YILING PHARM 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 1.

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
A210401-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2018-03-07
A210401-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2018-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210401-001	AB
A210401-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210401-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210401-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210401-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210401-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210401-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210401-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210401-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210401-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210401-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210401-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210401-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210401-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210401-002	AB	1	`782e0a99824c…`

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 1 of 1 · 16 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	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Westminster Pharmaceuticals, LLC	f352a641-988e-4878-8016-2b69cd6ee548	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	69e5455e-d0be-4c2b-b9ab-458b5480ed57	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	2e6a3667-af06-40de-80c0-8c4346e0671f	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	75334fc5-d236-401a-875c-f4f9c7749c1a	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	67e7b340-0635-2595-e053-2a91aa0ad266	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (product): 69117-0019
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	677edfd5-2d04-b932-e053-2a91aa0a26b0	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (product): 69117-0018
Acyclovir	ACYCLOVIR	Redpharm Drug	37453bcd-e34e-5902-e063-6294a90a0245	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Chartwell RX, LLC	8cd22728-34b4-4e55-8339-580138fe46d8	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (product): 62135-019
Acyclovir	ACYCLOVIR	Proficient Rx LP	d0908b3c-f5dd-4113-9080-bb01abe13c9c	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8d171c3d-de39-4f82-bacb-3e8d71b16540	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (product): 71335-1222
Acyclovir	ACYCLOVIR	A-S Medication Solutions	b96e44ca-aa54-4a64-89f4-fb5a5932ceae	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	c0c29e0f-b6e2-49df-88d1-95b7b625d356	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6ea3e3f6-132d-4b15-ac58-336de05201a7	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Proficient Rx LP	290af212-7332-4914-9ef0-65760478fb32	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (product): 71205-472
Acyclovir	ACYCLOVIR	Proficient Rx LP	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53002-0083	Acyclovir	Acyclovir	RPK Pharmaceuticals, Inc.	ANDA	Current
62135-019	Acyclovir	Acyclovir	Chartwell RX, LLC	ANDA	Current
68071-4790	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4790	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5006	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5006	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5006	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7342	Acyclovir	Acyclovir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7342	Acyclovir	Acyclovir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7342	Acyclovir	Acyclovir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7436	Acyclovir	Acyclovir	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7436	Acyclovir	Acyclovir	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7436	Acyclovir	Acyclovir	Preferred Pharmaceuticals, Inc.	ANDA	Current
69117-0018	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0018	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0018	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0018	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0018	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0019	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0019	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
69117-0019	Acyclovir	Acyclovir	YILING PHARMACEUTICAL, INC.	ANDA	Current
70518-1900	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1942	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1942	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1942	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1942	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-1942	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-2032	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70518-2321	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70934-401	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-401	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-408	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-408	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-472	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71205-472	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71335-1077	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1077	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1077	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1111	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1111	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1111	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1222	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1222	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1222	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1284	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1284	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1284	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
81288-018	Acyclovir	Acyclovir	EMC PHARMA, LLC	ANDA	Current
81288-019	Acyclovir	Acyclovir	EMC PHARMA, LLC	ANDA	Current