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 5 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	A-S Medication Solutions	65b38519-1d8a-4aca-b415-c64cca84d085	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Chartwell RX, LLC.	3c459965-2d42-488b-80c4-ce801f94839c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	e46059e1-3ce9-4a3c-80ce-464b140600ce	2024-09-28	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	216660f3-0329-ef7d-e063-6294a90a17df	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	fe6fff2f-f95c-4057-a71b-7ef6c5d415cc	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	e186afb5-7531-45ea-b785-c230483a7747	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f1439d25-3d3d-4fe5-b6e7-d76e62892969	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	549bf887-1ef6-6a75-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8a691ff2-eb16-4357-87ee-0ac9c99a5cb7	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9694f7a6-bcec-4809-b261-cdd3740968cb	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	e43271ef-c145-4145-b7f0-a02c237de2b5	2024-08-02	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	28fec572-e3b9-448c-8626-5c0920f38eeb	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f4ced8c7-a276-4a44-a60c-f8d1689a2bdf	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6e5f9616-ddf2-19c4-e053-2991aa0a372a	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ada33464-b416-9ac6-e053-2a95a90af787	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ade02343-3e4b-b1f1-e053-2995a90ac5fe	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	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.