Application 218947

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	TABLET;ORAL	EQ 250MG BASE	No	No
002	CEPHALEXIN	CEPHALEXIN	TABLET;ORAL	EQ 500MG BASE	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
A218947-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB		2024-09-27
A218947-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB		2024-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218947-001	AB
A218947-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218947-001	CEPHALEXIN	EQ 250MG BASE	TABLET / ORAL	AB	2024-09-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218947-002	CEPHALEXIN	EQ 500MG BASE	TABLET / ORAL	AB	2024-09-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218947-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218947-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218947-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218947-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218947-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218947-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218947-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218947-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218947-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218947-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218947-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218947-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218947-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218947-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218947-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218947-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218947-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218947-002	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218947-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218947-002	AB	1	`a50c72e98297…`

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 3 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3fed2817-fc0d-43cd-9f02-948fbc76672c	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
CEPHALEXIN	CEPHALEXIN	Direct_Rx	90148caf-4291-da8b-e053-2a95a90a9bd3	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: CEPHALEXIN generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Sportpharm LLC	3d5a2665-65da-4b10-9e23-39fc88145da1	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Sportpharm LLC	75820198-5efe-4ba0-ad50-e88d22fe075e	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ee278959-d321-d356-e053-2995a90a32c2	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AVKARE	74f83298-57f7-4166-8dd8-db3e556a68d8	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Chartwell RX, LLC	8a09bccd-1864-4dc3-9c31-6187d8e0fc99	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Chartwell RX, LLC	d315cce8-9784-419e-818b-16d68d1dbd6e	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	13444dc7-7da1-4181-a9ac-d95d4a235e6d	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	QPharma Inc	a9d2e29e-9c3f-429d-9d22-481807becd33	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	QPharma Inc	e8b3ece4-cf73-416c-8767-68f425df35f8	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	QPharma Inc	4e9a8ed3-c490-4a0e-bb29-5eea506f893b	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	QPharma Inc	c0e0533c-da78-7109-e053-2a95a90a4f5c	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	0b3da88f-f513-cdf0-e063-6394a90a7205	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11efa03d-0da9-419a-b53d-65a5671dccb0	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	c7028200-b141-496b-89e9-491558d4c879	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	6ce11859-aa21-4b3f-bd59-3cd26deca82b	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	5f867aa3-ea64-4a14-a63b-979b8ff8d80c	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	2070b988-f7fb-4e35-91e3-1b7df5e5326c	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AvPAK	5975f293-8bb3-3242-aca7-d7d0c7e1bdc8	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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