Application 090702

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A090702-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25
A090702-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25
A090702-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090702-001	AB
A090702-002	AB
A090702-003	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 1 of 4 · 123 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	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lithium carbonate	LITHIUM CARBONATE	Coupler LLC	582697c1-063f-366f-e063-6294a90a8d1b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	01c4facd-ed79-4078-ba33-2044de372d0f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	bfececc8-b2ab-47d1-b126-1c6592bc9c26	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702 ndc (product): 71335-0120
lithium carbonate	LITHIUM CARBONATE	Camber Pharmaceuticals, Inc.	04518b80-7563-4544-bf05-04f286223faa	2022-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702 ndc (product): 31722-544 ndc (product): 31722-545 ndc (product): 31722-546
lithium carbonate	LITHIUM CARBONATE	Aphena Pharma Solutions - Tennessee, LLC	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702 ndc (product): 71610-557
Lithium Carbonate	LITHIUM CARBONATE	Proficient Rx LP	d3291474-8ef2-4cd8-aecc-2f550fd6a299	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702 ndc (product): 63187-304

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8302	Lithium Carbonate	Lithium Carbonate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
31722-544	Lithium Carbonate	Lithium Carbonate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-544	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-544	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-544	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-544	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-544	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-545	Lithium Carbonate	Lithium Carbonate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-545	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-545	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-545	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-545	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-545	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-546	Lithium Carbonate	Lithium Carbonate	Camber Pharmaceuticals Inc.	ANDA	Current
31722-546	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-546	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-546	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-546	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-546	lithium carbonate	lithium carbonate	Camber Pharmaceuticals, Inc.	ANDA	Current
33261-852	Lithium Carbonate	Lithium Carbonate	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-3917	Lithium Carbonate	lithium carbonate	A-S Medication Solutions	ANDA	Current
50090-3917	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	ANDA	Current
50090-3917	Lithium Carbonate	lithium carbonate	A-S Medication Solutions	ANDA	Current
50090-3917	Lithium Carbonate	lithium carbonate	A-S Medication Solutions	ANDA	Current
50090-3918	Lithium Carbonate	Lithium Carbonate	A-S Medication Solutions	ANDA	Current
50090-3918	Lithium Carbonate	lithium carbonate	A-S Medication Solutions	ANDA	Current
58118-0545	Lithium Carbonate	Lithium Carbonate	Clinical Solutions Wholesale	ANDA	Current
58118-0545	Lithium Carbonate	Lithium Carbonate	Clinical Solutions Wholesale	ANDA	Current
58118-0545	Lithium Carbonate	Lithium Carbonate	Clinical Solutions Wholesale	ANDA	Current
63187-304	Lithium Carbonate	Lithium Carbonate	Proficient Rx LP	ANDA	Current
63187-304	Lithium Carbonate	Lithium Carbonate	Proficient Rx LP	ANDA	Current
63629-1916	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-1916	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-1916	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-1917	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-1917	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-1917	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
63629-9190	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
64725-0544	Lithium Carbonate	Lithium Carbonate	TYA Pharmaceuticals	ANDA	Current
64725-0545	Lithium Carbonate	Lithium Carbonate	TYA Pharmaceuticals	ANDA	Current
65977-5044	Lithium Carbonate	Lithium Carbonate	Hetero Drugs Limited	ANDA	Current
65977-5045	Lithium Carbonate	Lithium Carbonate	Hetero Drugs Limited	ANDA	Current
65977-5046	Lithium Carbonate	Lithium Carbonate	Hetero Drugs Limited	ANDA	Current
67046-432	Lithium Carbonate	Lithium Carbonate	Contract Pharmacy Services-PA	ANDA	Current
68071-2186	Lithium Carbonate	Lithium Carbonate	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-0437	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0437	lithium carbonate	lithium carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0437	lithium carbonate	lithium carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0437	lithium carbonate	lithium carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1753	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1753	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1753	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1753	lithium carbonate	lithium carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1753	lithium carbonate	lithium carbonate	REMEDYREPACK INC.	ANDA	Current
71335-0120	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
71335-0120	lithium carbonate	lithium carbonate	Bryant Ranch Prepack	ANDA	Current
71610-557	lithium carbonate	lithium carbonate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current