Application 206261

Type: ANDA
Sponsor: CARLSBAD TECHNOLOGY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206261-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2017-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206261-001	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 · 41 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	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206261-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	0d99ba77-c3c5-1fd0-e063-6294a90a6f2a	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	af9d41f5-4658-4487-8811-32a1f8af9384	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 63629-2009
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	01ae85df-d1a0-44f7-b4c0-0ac74d2216d4	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 71335-1290
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	37499620-6a17-40f1-b0db-dd79320ea21d	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 61442-114
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b455053f-3deb-bd76-e053-2a95a90a9869	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 68071-2299
Acyclovir	ACYCLOVIR	Proficient Rx LP	e8056ec6-d2dc-48af-8550-82726af1c5c5	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 71205-578

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-6030	Acyclovir	Acyclovir	Liberty Pharmaceuticals, Inc.	ANDA	Current
43063-888	Acyclovir	Acyclovir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3902	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
50090-3902	Acyclovir	Acyclovir	A-S Medication Solutions	ANDA	Current
61442-114	Acyclovir	Acyclovir	Carlsbad Technology, Inc.	ANDA	Current
63629-2009	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-2009	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-7636	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
63629-7636	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
68071-2299	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2299	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-578	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71205-578	Acyclovir	Acyclovir	Proficient Rx LP	ANDA	Current
71335-1290	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1290	Acyclovir	Acyclovir	Bryant Ranch Prepack	ANDA	Current
72275-733	Acyclovix	Acyclovir	Primary Pharmaceuticals, Inc.	ANDA	Current