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 7 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Advanced Rx Pharmacy of Tennessee, LLC	b6ffe633-dd91-6d49-e053-2a95a90a5ac6	2024-01-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9a1f2ab7-d8af-444f-96c2-56b666d4c79a	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	ea10d05a-2e39-4a30-8935-5555bc1e515e	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ab3fc544-3652-4de5-a7ff-e013adb69b5a	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ee0603a5-0758-4968-89e3-1aa95e9967f2	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	18518154-30ba-48a4-852a-3a7723030071	2023-12-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	Proficient Rx LP	829244bd-93da-4a5a-a257-890cfec4c06d	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Major Pharmaceuticals	1c1fbad7-bef4-42a0-a8c9-b35168f5d533	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	2cb7bc3a-988b-4414-8036-fb09b2ab5767	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	b270d537-878b-4468-b246-b704adb29ced	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	445b2a87-2e4f-483a-abe8-26fefd67514a	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	8073f183-e11f-41af-8bd1-1505bc7e044b	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	A-S Medication Solutions	0a24b6e5-6f13-44b4-93f4-47c86945cad2	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: cephalexin generic name: CEPHALEXIN
CEPHALEXIN	CEPHALEXIN	DIRECT RX	2d12e6a9-f7dd-25ed-e054-00144ff8d46c	2022-09-29	Warnings, Adverse reactions	Name fallback brand name: CEPHALEXIN generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	891b8c0e-dbf4-4b0e-ba3f-c4c49d51510d	2022-07-20	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	febab51b-6b48-488a-8fd1-d24400e5df1d	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	ada7b8a5-98f4-454c-b38f-92192d4db33f	2021-08-01	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Pharma-C, Inc.	bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c	2016-12-09	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.