Application 065378

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	200MG/5ML	No	No
002	AMOXICILLIN	AMOXICILLIN	FOR SUSPENSION;ORAL	400MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065378-001	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26
A065378-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065378-001	AB
A065378-002	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 3 · 84 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	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A065378-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065378-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065378-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065378-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065378-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065378-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065378-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065378-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065378-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065378-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065378-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065378-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065378-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065378-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065378-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065378-002	AB	1	`bb7c543d1eb4…`

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
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	669a243e-249d-4ccb-9693-66de073e53bb	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	81fe142e-a163-4632-93fb-7cd8d80c50bd	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	830bb8fb-3743-463a-9317-3f83e3e105ac	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	997650f9-7eff-64de-e053-2995a90a617b	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378 ndc (product): 68071-5127
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378 ndc (product): 0781-6157 ndc (product): 0781-6156
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ead1e453-af08-4a3b-8379-aa182dff514b	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378 ndc (product): 71205-436

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
0781-6156	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6156	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6156	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6156	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6156	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6157	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6157	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6157	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6157	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
0781-6157	Amoxicillin	Amoxicillin	Sandoz Inc	ANDA	Current
50090-5215	Amoxicillin	Amoxicillin	A-S Medication Solutions	ANDA	Current
53002-1369	Amoxicillin	Amoxicillin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1369	Amoxicillin	Amoxicillin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-467	Amoxicillin	Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-672	AMOXICILLIN	AMOXICILLIN	DIRECTRX	ANDA	Current
67253-147	Amoxicillin	Amoxicillin	DAVA Pharmaceuticals Inc	ANDA	Current
67253-149	Amoxicillin	Amoxicillin	DAVA Pharmaceuticals Inc	ANDA	Current
68071-1826	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4192	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5127	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5127	Amoxicillin	Amoxicillin	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-436	Amoxicillin	Amoxicillin	Proficient Rx LP	ANDA	Current