Application 079159

Type: ANDA
Sponsor: ALEMBIC LTD

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 42.

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
A079159-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12
A079159-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12
A079159-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079159-001	AB
A079159-002	AB
A079159-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079159-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-01-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A079159-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079159-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079159-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079159-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079159-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079159-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079159-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079159-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079159-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079159-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079159-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079159-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079159-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079159-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079159-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079159-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079159-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079159-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079159-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079159-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079159-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079159-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Limited	d1800f34-3d67-4b2f-874e-8639b125d853	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079159 application number: ANDA079159 ndc (product): 46708-304 ndc (product): 46708-303 ndc (product): 46708-305
LITHIUM CARBONATE LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	4ca2b977-b94c-4232-9b7e-835db97c9544	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079159 application number: ANDA079159 ndc (product): 62332-014 ndc (product): 62332-015 ndc (product): 62332-013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-303	Lithium Carbonate	Lithium Carbonate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-304	Lithium Carbonate	Lithium Carbonate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-305	Lithium Carbonate	Lithium Carbonate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-013	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-013	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-013	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-013	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-013	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-014	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-014	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-014	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-014	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-014	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-015	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-015	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-015	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-015	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-015	LITHIUM CARBONATE	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	ANDA	Current
68788-7716	LITHIUM CARBONATE	LITHIUM CARBONATE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7716	LITHIUM CARBONATE	LITHIUM CARBONATE	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1067	LITHIUM CARBONATE	LITHIUM CARBONATE	Bryant Ranch Prepack	ANDA	Current
71335-1067	LITHIUM CARBONATE	LITHIUM CARBONATE	Bryant Ranch Prepack	ANDA	Current