Application 076490

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076490-001	LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL			2003-06-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076490-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-17	`f41ea6bd6efb…`

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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	A-S Medication Solutions	baf59ee7-1c98-4f77-96c5-7b50b7acb8f4	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium carbonicum	LITHIUM CARBONATE	Boiron	861df6e6-46cb-632d-e053-2a91aa0ae9a3	2023-11-13		Name fallback generic name: LITHIUM CARBONATE
Lithium carbonicum	LITHIUM CARBONATE	Boiron	68f8e2a1-0fe9-70e4-e053-2a91aa0a981d	2023-11-13		Name fallback generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Sun Pharmaceutical Industries, Inc.	d3284649-ed4c-4096-987b-4ac16b8278f2	2023-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	204d94de-83e4-400e-bd6b-70b49813802c	2023-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	a226a88d-eb57-4c96-afda-939801bca0a9	2023-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
lithium carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	bfececc8-b2ab-47d1-b126-1c6592bc9c26	2023-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lithium carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Limited	8e950a50-689d-4bf8-87ce-cffd43c6d5c2	2023-01-30	Boxed warning, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Limited	d1800f34-3d67-4b2f-874e-8639b125d853	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
lithium carbonate	LITHIUM CARBONATE	Camber Pharmaceuticals, Inc.	04518b80-7563-4544-bf05-04f286223faa	2022-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lithium carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	2022-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
LITHIUM CARBONATE LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	4ca2b977-b94c-4232-9b7e-835db97c9544	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LITHIUM CARBONATE
lithium carbonate	LITHIUM CARBONATE	Aphena Pharma Solutions - Tennessee, LLC	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	2021-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lithium carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Proficient Rx LP	d3291474-8ef2-4cd8-aecc-2f550fd6a299	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1277	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceutical Corp	ANDA	Current