Application 018027

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHOBID	LITHIUM CARBONATE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018027-001	LITHOBID	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018027-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018027-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018027-001	AB	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LITHOBID	LITHIUM CARBONATE	ANI Pharmaceuticals, Inc.	f7f5b69a-c2a1-4586-a189-1475d41387c0	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018027 application number: NDA018027 ndc (product): 62559-280

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-280	LITHOBID	lithium carbonate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-280	LITHOBID	lithium carbonate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-280	LITHOBID	lithium carbonate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-280	LITHOBID	lithium carbonate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-280	LITHOBID	lithium carbonate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-340	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-340	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-340	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-340	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-340	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
63629-1955	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-1955	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-1955	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
70518-0629	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	REMEDYREPACK INC.	NDA AUTHORIZED	Current
70518-0629	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71205-238	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
71205-238	Lithium Carbonate	Lithium Carbonate Extended-Release Tablet	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
71335-1543	Lithium Carbonate	Lithium Carbonate Extended-Release	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1543	Lithium Carbonate	Lithium Carbonate Extended-Release	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72381	SUPPL	2022-10-17
72324	SUPPL	2022-10-14
61858	SUPPL	2020-02-10
61790	SUPPL	2020-02-06
57001	SUPPL	2018-12-21
56954	SUPPL	2018-12-21
54010	SUPPL	2018-05-03
53996	SUPPL	2018-05-03
33397	SUPPL	2016-06-01
791	SUPPL	2016-06-01
11121	SUPPL	2011-10-25
790	SUPPL	2011-10-24
40773	SUPPL	2008-04-02
789	SUPPL	2006-10-05
788	SUPPL	2006-04-13
33396	SUPPL	2002-10-07
33395	SUPPL	2002-10-07
13984	SUPPL	2002-10-07
13983	SUPPL	2002-10-07
11120	SUPPL	2002-10-07
787	SUPPL	2002-10-07