Application 209366

Type: ANDA
Sponsor: SQUARE PHARMS 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
A209366-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2019-10-07
A209366-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209366-001	AB
A209366-002	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 2 · 78 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	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A209366-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209366-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209366-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209366-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209366-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209366-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209366-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209366-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209366-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209366-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209366-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209366-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209366-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209366-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209366-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209366-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209366-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209366-002	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	37a51d9c-1f39-4065-8c7d-6528ac6de91c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc.	b1033fda-8242-4006-b1cd-23474d70671f	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (product): 68788-8203
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	a1086845-ba08-4fb2-81dc-aea9c68bf2c3	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Direct_Rx	387d33ed-45e5-42d6-e063-6294a90afbb7	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	067109d0-2539-42b6-9e95-102b58ca54dc	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	713960c2-8278-4778-b781-08ec89a9cfce	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	116f4f0d-66c5-49dd-e063-6394a90ab2b5	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	e5e99a6b-79a6-7fdb-e053-2a95a90a8563	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (product): 68071-2811
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e73ae5c8-7a77-4330-817d-482d1de4e994	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (product): 71335-9620
Acyclovir	ACYCLOVIR	Bionpharma Inc.	6f1db9f0-9b41-4fb7-8798-44fdc2c128df	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (product): 69452-290 ndc (product): 69452-291
Acyclovir	ACYCLOVIR	SQUARE PHARMACEUTICALS LIMITED	b24201ea-aeae-4de1-b01b-eee89068e786	2023-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (product): 76483-042 ndc (product): 76483-047
Acyclovir	ACYCLOVIR	A-S Medication Solutions	34a38cdf-04e8-4006-a9f5-4a0831117d61	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-2811	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2811	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2811	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2854	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8203	Acyclovir	Acyclovir	Preferred Pharmaceuticals Inc.	ANDA	Current
69452-290	Acyclovir	Acyclovir	Bionpharma Inc.	ANDA	Current
69452-290	Acyclovir	Acyclovir	Bionpharma Inc.	ANDA	Current
69452-291	Acyclovir	Acyclovir	Bionpharma Inc.	ANDA	Current
69452-291	Acyclovir	Acyclovir	Bionpharma Inc.	ANDA	Current
71335-9620	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
76483-042	Acyclovir	Acyclovir	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-047	Acyclovir	Acyclovir	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current