Application 050460

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	AMOXIL	AMOXICILLIN	FOR SUSPENSION;ORAL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	LAROTID	AMOXICILLIN	FOR SUSPENSION;ORAL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N050460-001	AMOXIL	AMOXICILLIN	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982
N050460-002	AMOXIL	AMOXICILLIN	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982
N050460-005	AMOXIL	AMOXICILLIN	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982
N050460-006	LAROTID	AMOXICILLIN	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050460-001	AMOXIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050460-002	AMOXIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050460-005	AMOXIL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050460-006	LAROTID	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD, Approved before 1982	`ea99ee380514…`

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 11 · 217 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	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	b6ea2f81-aee6-4c88-b681-50eb28e80a86	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	5a79669f-52f7-e8ea-e063-6394a90a93b8	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	f37eb415-77b2-41b0-8d20-64e821e4b05d	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	Redpharm Drug	5a660370-9a81-33f9-e063-6394a90a6c62	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	c4d4aeca-f63c-4548-a9b7-7f627e8fd45c	2026-08-29	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	82c0c5d1-df2d-4352-bd12-99f955af569e	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	3a4afd36-dffa-44a1-9d09-e93cf66053bf	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	afb4149a-0714-4a85-b9e8-2379a8e6a302	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Coupler LLC	5827b6de-6b48-d73a-e063-6394a90a4a72	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8cb987bf-d45a-c15a-e053-2995a90aad46	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	57f5652d-ee50-eb7e-e063-6394a90a7b66	2026-08-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Redpharm Drug	57e56202-950b-10f6-e063-6394a90a4912	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	4a402dba-c255-5db8-e054-00144ff8d46c	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	a2c91cf0-a4e4-44c0-b712-bee63dd6c22b	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	102c62ca-da20-4866-84a8-e3513824af4a	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	9618d038-e880-47f6-b8d7-bbf8ab35364d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	bf130964-8386-4ab7-8d3b-fb0174670afc	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	18a4f555-a537-4c40-9bb2-dc3bd782fa27	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN

Reported adverse events (FAERS/openFDA)#

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