Application 202229

Type: ANDA
Sponsor: GLENMARK GENERICS

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	Yes

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
A202229-001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202229-001	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	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL			2013-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202229-001	ACAMPROSATE CALCIUM	333MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2013-07-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202229-001	AB	1	`6a471c1ec25d…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202229-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202229-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202229-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202229-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202229-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202229-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202229-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202229-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202229-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202229-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202229-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202229-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202229-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202229-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202229-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202229-001	AB	1	`a50c72e98297…`

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	Major Pharmaceuticals	ae6e79c0-a307-4888-b647-1b7be4cb9127	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229 ndc (product): 0904-7213
Acamprosate Calcium	ACAMPROSATE CALCIUM	Glenmark Pharmaceuticals Inc., USA	43e9ef60-2d85-4394-906b-93042fea099a	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229 ndc (product): 68462-435
Acamprosate Calcium	ACAMPROSATE CALCIUM	American Health Packaging	94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202229 application number: ANDA202229 ndc (product): 60687-121

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
0904-7213	Acamprosate Calcium	Acamprosate Calcium	Major Pharmaceuticals	ANDA	Current
10135-636	Acamprosate Calcium	Acamprosate Calcium	Marlex Pharmaceuticals Inc	ANDA	Current
10135-636	Acamprosate Calcium	Acamprosate Calcium	Marlex Pharmaceuticals Inc	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32209	ORIG	2013-07-18