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 6 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	3fcb3f88-9dfc-444d-952a-1d1967720525	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	4eb58a7e-1c92-4be3-b702-e522e0fbf425	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	90a76d24-e5a9-9000-e053-2a95a90ae8af	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6be20569-df34-04d9-e053-2991aa0a94fd	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	681c235f-6dee-1401-e053-2991aa0addc0	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	fc426d0d-9774-4189-8d83-89aa85d926bb	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	712a6789-7aab-4114-ae92-d1c7686c6b96	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	5b7666f3-4014-45ce-8387-3298d9fe6d25	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	141bd050-5dfc-68fa-e063-6394a90a6d86	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af49507d-254f-296d-e053-2a95a90ad263	2024-03-12	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	4fccce5a-4e39-46cd-976a-32ff71189520	2024-03-08	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	92be9844-0775-4808-bdeb-dccb09647d91	2024-03-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	A-S Medication Solutions	d31da5be-c939-4aa0-adb8-b26a1396b228	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	0edeb103-5e94-4f42-828f-c7336486c784	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f501f3a9-48e9-451a-a4b6-46d268b7bd3d	2024-01-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8d25d863-9ec2-4b76-b2e5-d4e2e39639a5	2024-01-18	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.