Application 091616

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	No

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
A091616-001	LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091616-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`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	A091616-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091616-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091616-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091616-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091616-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091616-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091616-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091616-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091616-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091616-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091616-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091616-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091616-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091616-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091616-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091616-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091616-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091616-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091616-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091616-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091616-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091616-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091616-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091616-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091616-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091616-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091616-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091616-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091616-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091616-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091616-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091616-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091616-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091616-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091616-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091616-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091616-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091616-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091616-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091616-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate ER	LITHIUM CARBONATE	Coupler LLC	51b503f5-211f-a9cc-e063-6294a90a9895	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616
Lithium Carbonate ER	LITHIUM CARBONATE	REMEDYREPACK INC.	bd4b07d3-ce42-440f-aec3-19f4d1c445a9	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616
Lithium Carbonate ER	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	525a9d9b-cbb1-4644-a28a-8bba96f09348	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616 ndc (product): 68462-224
Lithium Carbonate ER	LITHIUM CARBONATE	AvKARE	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616 ndc (product): 42291-496

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-496	Lithium Carbonate	Lithium Carbonate	AvKARE	ANDA	Current
63629-7903	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
63629-7903	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
68462-224	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-224	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-224	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current