Application 065319

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	400MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065319-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2007-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065319-002	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 · 43 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
2026-09-14 22:38:34	2026-08	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A065319-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065319-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065319-002	AB	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
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065319 application number: ANDA065319

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.