Application 076832

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	TABLET, EXTENDED RELEASE;ORAL	300MG	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
A076832-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076832-001	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	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`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	A076832-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	453721b5-b1f5-4161-8e01-8b4803151dc5	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (product): 68084-640
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	039f188c-413a-6e64-e063-6294a90a2972	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (product): 72789-171
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c2635909-7ab2-4c05-9a42-2819702dba63	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (product): 72789-171
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (product): 0054-0021

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0021	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0021	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0021	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0021	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0021	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0021	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0615-5593	Lithium Carbonate	Lithium Carbonate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
68084-640	Lithium Carbonate	Lithium Carbonate	American Health Packaging	ANDA	Current
68084-640	Lithium Carbonate	Lithium Carbonate	American Health Packaging	ANDA	Current
68084-640	Lithium Carbonate	Lithium Carbonate	American Health Packaging	ANDA	Current
68084-640	Lithium Carbonate	Lithium Carbonate	American Health Packaging	ANDA	Current
68084-640	Lithium Carbonate	Lithium Carbonate	American Health Packaging	ANDA	Current
68151-0639	Lithium Carbonate	Lithium Carbonate	Carilion Materials Management	ANDA	Current
72789-171	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-171	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-171	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-171	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22592	ORIG	2011-12-16