Application 076121

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	300MG	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
A076121-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL			2001-09-27

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	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076121-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	2001-09-27	`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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate ER	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	525a9d9b-cbb1-4644-a28a-8bba96f09348	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	db3dc13f-d532-4fcd-a235-c9efab9e6bd7	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	1b65d27e-5086-4a87-8387-c49f3d060978	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate ER	LITHIUM CARBONATE	AvKARE	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	63b3790f-a9b5-47f4-bae1-ddf8b43c13c1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	d276da3c-9952-4674-a54d-b1258df71b8a	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	039f188c-413a-6e64-e063-6294a90a2972	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	edfceebd-a3e4-4905-bffe-cdc0b948dcd2	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	16ebe1f9-501d-468b-a37d-f6a46f8f32d1	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c4973d87-d014-42f4-ba13-ae628ca1a451	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium carbonate	LITHIUM CARBONATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	074e3c3b-3a36-4c66-b0a7-e19f9aac8548	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Coupler LLC	3dfeeb11-a096-ae17-e063-6294a90a9aae	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Rising Pharma Holdings, Inc.	5e18d105-662d-4729-aa81-00be7472adde	2025-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Rising Pharma Holdings, Inc.	3418bdb6-12ac-4626-9de5-44987b73ae89	2025-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c2635909-7ab2-4c05-9a42-2819702dba63	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	d20ed2aa-aa56-4709-9e7a-9243c71465c9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	a1e2f942-2bc0-4afd-91ad-6c4cab38c8f0	2024-12-12	Boxed warning, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	203386e3-718f-7c84-e063-6394a90aed34	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lithium Carbonate generic name: LITHIUM CARBONATE
Lithium Carbonate	LITHIUM CARBONATE	A-S Medication Solutions	3c996da2-c606-4043-9992-5bfb7f9b97a7	2024-04-03	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22539	ORIG	2005-07-22
31080	ORIG	2003-04-16