Application 017812

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	300MG	Yes	No
002	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	150MG	Yes	No
003	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	600MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017812-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017812-002	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28
N017812-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017812-001	AB
N017812-002	AB
N017812-003	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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017812-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017812-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017812-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017812-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017812-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017812-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017812-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017812-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017812-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017812-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017812-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017812-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-001	AB	1	`79d66fd596c7…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	b839ff4b-f62d-41ab-a823-550a756d58ec	2026-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	05312159-3d8a-45e0-99cb-b83a7b200cd3	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812 ndc (product): 70518-1434
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	c84cce95-cfcb-4426-aac6-d2f48f946ada	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 70518-1481
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	b074ca9f-66b2-4e83-b67d-cb317b46411b	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812 ndc (product): 70518-2345
Lithium Carbonate	LITHIUM CARBONATE	Cardinal Health 107, LLC	0e6b0a2d-b79c-44d8-b785-5267df9e8f72	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812 ndc (product): 55154-4920
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	16ebe1f9-501d-468b-a37d-f6a46f8f32d1	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812 ndc (product): 72789-172
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c4973d87-d014-42f4-ba13-ae628ca1a451	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	2022-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812 ndc (product): 0054-8526 ndc (product): 0054-8531 ndc (product): 0054-2526 ndc (product): 0054-2531 ndc (product): 0054-8527 ndc (product): 0054-2527

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 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-2526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-2531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8526	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8531	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0615-1311	Lithium Carbonate	Lithium Carbonate	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-2304	Lithium Carbonate	Lithium Carbonate	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
50090-1722	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
50090-2799	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
50090-2799	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
50090-2799	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
50090-2959	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
50090-2959	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	NDA	Current
53808-0705	Lithium Carbonate	Lithium Carbonate	State of Florida DOH Central Pharmacy	NDA	Current
55154-4920	Lithium Carbonate	Lithium Carbonate	Cardinal Health 107, LLC	NDA	Current
55154-4920	Lithium Carbonate	Lithium Carbonate	Cardinal Health	NDA	Current
55154-4920	Lithium Carbonate	Lithium Carbonate	Cardinal Health	NDA	Current
55154-4920	Lithium Carbonate	Lithium Carbonate	Cardinal Health	NDA	Current
64725-2527	Lithium Carbonate	Lithium Carbonate	TYA Pharmaceuticals	NDA	Current
67046-397	Lithium Carbonate	Lithium Carbonate	Contract Pharmacy Services-PA	NDA	Current
67046-430	Lithium Carbonate	Lithium Carbonate	Contract Pharmacy Services-PA	NDA	Current
67544-534	Lithium Carbonate	Lithium Carbonate	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-946	Lithium Carbonate	Lithium Carbonate	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
70518-1434	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1434	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1434	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1434	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1434	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1481	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-1481	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
70518-2345	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
72789-172	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72383	SUPPL	2022-10-17
72382	SUPPL	2022-10-17
72341	SUPPL	2022-10-14
61833	SUPPL	2020-02-06
61832	SUPPL	2020-02-06
61782	SUPPL	2020-02-06
56996	SUPPL	2018-12-21
56995	SUPPL	2018-12-21
56955	SUPPL	2018-12-21
55922	SUPPL	2018-10-15
55917	SUPPL	2018-10-15
55889	SUPPL	2018-10-11
45760	SUPPL	2016-11-01
45709	SUPPL	2016-10-28
33350	SUPPL	2011-10-25
13908	SUPPL	2011-10-25
711	SUPPL	2003-01-31
13907	SUPPL	2001-11-26
13906	SUPPL	2001-11-26
13905	SUPPL	2001-11-26
13904	SUPPL	2001-11-26
709	SUPPL	2001-11-26
710	SUPPL	2001-06-14