Application 062226

Type: ANDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	125MG/5ML	No	No
002	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	250MG/5ML	No	No
003	LAROTID	AMOXICILLIN	FOR SUSPENSION;ORAL	125MG/5ML	No	No
004	LAROTID	AMOXICILLIN	FOR SUSPENSION;ORAL	250MG/5ML	No	No
005	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	50MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A062226-001	AMOXIL	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982
A062226-002	AMOXIL	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982
A062226-003	LAROTID	AMOXICILLIN	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982
A062226-004	LAROTID	AMOXICILLIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982
A062226-005	AMOXIL	AMOXICILLIN	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A062226-001	AB
A062226-002	AB
A062226-003	AB
A062226-004	AB
A062226-005	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-001	AMOXIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-002	AMOXIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-003	LAROTID	125MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-004	LAROTID	250MG/5ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-005	AMOXIL	50MG/ML	FOR SUSPENSION / ORAL	AB	Approved before 1982	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062226-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062226-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062226-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062226-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062226-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062226-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062226-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062226-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062226-005	AB	1	`03ed91905a0d…`

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 9 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6e9bf369-2f96-c7ae-e053-2a91aa0a715f	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	7524da98-b0a5-3db8-e053-2a91aa0a6ff1	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	234d0dfc-cb24-413f-b798-129c73eb848e	2024-06-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	7b182161-128e-430c-98b2-592c242ba711	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	260a3a79-9dd6-4c4b-82ec-f8050346e886	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	aee851cf-428e-4d29-a281-078fe00c56b0	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	9925773d-8ea1-4193-91e3-52cc1ce5ca67	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	14a5f8c2-fdaf-4ad4-982b-c5aa128e242d	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	7db086c6-a56b-4848-9eec-abaaff9f5b6f	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	d5ecb620-5267-4dcf-be81-64c7766516f5	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	a2a5bb34-671b-499c-b8b4-c40fb51af09a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3d8a700b-b23b-459a-a19a-213dd39b6a3a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	efc66d77-1733-41e1-9aed-7c10a4b4ba96	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	322feb95-8bd4-440a-bda2-29ee19b11234	2024-04-15	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4d0f063a-d896-4757-8f22-9614e2ad71d4	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	73219f24-6eac-4472-b2a7-cad36936c185	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	26202694-cf20-4b08-90cc-70a3d30cbb0f	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN

Reported adverse events (FAERS/openFDA)#

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