Application 205995

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	TABLET, DELAYED RELEASE;ORAL	333MG	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
A205995-001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205995-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205995-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-05-26	`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	A205995-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205995-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205995-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205995-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205995-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205995-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205995-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205995-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205995-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205995-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205995-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205995-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205995-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205995-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205995-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205995-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205995-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205995-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205995-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205995-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205995-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205995-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205995-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205995-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205995-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205995-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205995-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205995-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205995-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205995-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205995-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205995-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205995-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205995-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205995-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205995-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205995-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205995-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205995-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205995-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acamprosate calcium	ACAMPROSATE CALCIUM	REMEDYREPACK INC.	91769a96-3182-4e38-90c3-b22c1beae398	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995
acamprosate calcium	ACAMPROSATE CALCIUM	Zydus Pharmaceuticals (USA) Inc.	9803db35-2600-4f42-80c1-43216fd1ba3d	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995 ndc (product): 68382-569
acamprosate calcium	ACAMPROSATE CALCIUM	Zydus Lifesciences Limited	0c729939-d2d2-4e61-acbc-4f1646dc38c1	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205995 application number: ANDA205995 ndc (product): 70771-1057

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-569	acamprosate calcium	acamprosate calcium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-569	acamprosate calcium	acamprosate calcium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-569	acamprosate calcium	acamprosate calcium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1057	acamprosate calcium	acamprosate calcium	Cadila Healthcare Limited	ANDA	Current
70771-1057	acamprosate calcium	acamprosate calcium	Cadila Healthcare Limited	ANDA	Current
70771-1057	acamprosate calcium	acamprosate calcium	Cadila Healthcare Limited	ANDA	Current