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 4 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	21392758-c033-4d4d-81c9-d10e132f95b7	2025-10-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	bff3912c-c39c-40c0-98d2-27c3d506c24d	2025-10-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AMELLA PHARMA, LLC	602fae70-3b8a-4f09-8db1-41fef4a2ecd7	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f3b46058-3e53-413b-b9c9-7d49e50f861e	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	88a744d8-a95e-4c63-8b25-52f5039b6ba1	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8d7f247a-3b42-4823-96fb-5f5c1bd94d49	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	1bfa8744-24ee-4c70-845c-c532b8084433	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	0aad51b4-86d5-e312-e063-6394a90a250d	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	50f0187b-09e7-4c11-970f-91cd1877fde1	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	905b3270-abbd-4d5c-b313-3d20eb4b4c57	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f2e73727-2ab6-4418-9677-19ea1d140bbd	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Coupler, LLC	30b7071e-cef1-bd41-e063-6394a90ad48e	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	28da5822-fb0b-1306-e063-6394a90a6e4c	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	02b5cd6f-3df8-43c1-879d-217fcf55231a	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	12f78d76-ea13-440c-8dd0-5aec86277acf	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Cronus Pharma LLC	a4e861e2-5803-4c4a-a962-92f5755e1ab5	2025-01-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	American Health Packaging	cb64cab2-5297-4ed2-a50a-2e5d5e14fa8d	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	a8f14231-5d43-46f7-ba1f-d6de8162d5e7	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	99ef59d5-bc44-4727-86fe-dc81357207c3	2024-10-25	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.