Application 062745

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEFLET	CEPHALEXIN	TABLET;ORAL	EQ 250MG BASE	No	No
002	KEFLET	CEPHALEXIN	TABLET;ORAL	EQ 500MG BASE	No	No

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

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
A062745-001	KEFLET	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL			1986-12-01
A062745-002	KEFLET	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL			1986-12-01

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062745-001	KEFLET	EQ 250MG BASE	TABLET / ORAL	1986-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062745-002	KEFLET	EQ 500MG BASE	TABLET / ORAL	1986-12-01	`74a2ff9319b5…`

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 8 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	8073f183-e11f-41af-8bd1-1505bc7e044b	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	A-S Medication Solutions	0a24b6e5-6f13-44b4-93f4-47c86945cad2	2023-04-26	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
CEPHALEXIN	CEPHALEXIN	DIRECT RX	2d12e6a9-f7dd-25ed-e054-00144ff8d46c	2022-09-29	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	891b8c0e-dbf4-4b0e-ba3f-c4c49d51510d	2022-07-20	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Ascend Laboratories, LLC	bb28751c-bd1b-4e7f-8271-a14c1b4314e3	2022-07-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	febab51b-6b48-488a-8fd1-d24400e5df1d	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	ada7b8a5-98f4-454c-b38f-92192d4db33f	2021-08-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	19307ff0-71de-477b-965d-ea243e5ede3a	2020-12-31	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Pharma-C, Inc.	bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c	2016-12-09	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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