Application 070755

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CITRATE	LITHIUM CITRATE	SYRUP;ORAL	EQ 300MG CARBONATE/5ML	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
A070755-001	LITHIUM CITRATE	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070755-001	AA

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		1986-05-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL			1986-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	1986-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	1986-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	1986-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	1986-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070755-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL		RS	1986-05-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A070755-001	AA	1	`caaa826d4ba7…`
2022-04-08 23:34 UTC	2022-04	A070755-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070755-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070755-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070755-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070755-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070755-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070755-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070755-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070755-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070755-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070755-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070755-001	AA	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A070755-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070755-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070755-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070755-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070755-001	AA	1	`a50c72e98297…`

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
Lithium	LITHIUM	PAI Holdings, LLC dba PAI Pharma	677b20c4-84f0-4716-aca3-aead3bbe1283	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070755 application number: ANDA070755