Application 062216

Type: ANDA
Sponsor: NEOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXIL	AMOXICILLIN	CAPSULE;ORAL	250MG	No	No
003	AMOXIL	AMOXICILLIN	CAPSULE; ORAL	250MG	No	No
004	AMOXIL	AMOXICILLIN	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A062216-001	AMOXIL	AMOXICILLIN	250MG	CAPSULE / ORAL	AB	Approved before 1982
A062216-004	AMOXIL	AMOXICILLIN	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062216-001	AB
A062216-004	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062216-001	AMOXIL	250MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062216-004	AMOXIL	500MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A062216-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062216-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062216-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062216-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062216-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062216-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062216-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062216-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062216-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062216-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062216-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062216-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062216-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062216-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062216-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062216-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062216-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062216-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062216-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062216-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062216-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062216-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062216-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062216-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062216-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062216-004	AB	1	`4b0b4de00fa7…`

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
AMOXICILLIN	AMOXICILLIN	REMEDYREPACK INC.	4adc198e-39d8-4b3e-bfa4-278aaf4064ae	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	5a660370-9a81-33f9-e063-6394a90a6c62	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216
AMOXICILLIN	AMOXICILLIN	USAntibiotics, LLC	110ba6b1-f175-48a1-8e30-616c02212538	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216 ndc (product): 81964-205 ndc (product): 81964-225
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	0a100e76-513c-98d3-e063-6294a90adf47	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062216 application number: ANDA062216

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-7812	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7812	Amoxicillin	Amoxicillin	Preferred Pharmaceuticals, Inc.	ANDA	Current
72508-205	Amoxicillin	Amoxicillin	Neopharma Inc	ANDA	Current
72508-205	Amoxicillin	Amoxicillin	Neopharma Inc	ANDA	Current
72508-225	Amoxicillin	Amoxicillin	Neopharma Inc	ANDA	Current
72508-225	Amoxicillin	Amoxicillin	Neopharma Inc	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-074	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-075	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-077	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-077	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-077	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-077	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-077	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-078	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-078	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-078	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-078	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-078	Amoxicillin	Amoxicillin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
81964-205	AMOXICILLIN	Amoxicillin	USAntibiotics, LLC	ANDA	Current
81964-205	AMOXICILLIN	Amoxicillin	USAntibiotics, LLC	ANDA	Current
81964-225	AMOXICILLIN	Amoxicillin	USAntibiotics, LLC	ANDA	Current
81964-225	AMOXICILLIN	Amoxicillin	USAntibiotics, LLC	ANDA	Current