Application 050405

Type: NDA
Sponsor: PRAGMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 250MG BASE	Yes	No
003	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 500MG BASE	Yes	No
004	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 750MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050405-002	KEFLEX	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-003	KEFLEX	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-004	KEFLEX	CEPHALEXIN	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12
N050405-005	KEFLEX	CEPHALEXIN	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12

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.

Product history page 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050405-002	KEFLEX	EQ 250MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050405-003	KEFLEX	EQ 500MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050405-005	KEFLEX	EQ 750MG BASE	CAPSULE / ORAL	RLD	2006-05-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050405-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050405-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050405-005	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050405-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050405-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050405-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050405-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050405-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050405-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050405-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050405-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050405-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050405-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050405-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050405-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050405-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050405-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050405-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050405-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050405-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050405-005	AB	1	`ea99ee380514…`

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 1 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e54df878-c235-4aa3-af33-fe5287c73138	2026-09-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	4ecf9314-76e2-c270-e063-6294a90ad8db	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c0ca008e-0e28-412e-a58f-70f63817713b	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	HAWAII REPACK, INC.	d54abc0a-3c8f-4f02-bd55-406f0c5b925a	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	864d2046-b2c8-415c-814b-512bc4901c76	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c600a2c0-42ab-4be8-b9b1-59ba39494b3f	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	af3e9919-3812-4917-bb6e-266a692ee4ab	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	a24a3c7c-c0f8-4107-ab30-751bea743d2d	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3dc725a0-6e4b-45c6-9569-34ef65455845	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e4e1ebcf-b43b-4dbe-9295-eeef67ba6272	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b73593ce-0b1f-4371-bae1-140742de3b42	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	d3527c0a-94e4-46a2-be77-d936abcd19ec	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AvKARE	03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	88426cb3-1c0c-439b-9f1a-aa169040c29f	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	655f38e8-1c4d-4cbc-9f52-bb881f065b2d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
59630-112	Keflex	cephalexin	Shionogi Inc.	NDA	Current
59630-113	Keflex	cephalexin	Shionogi Inc.	NDA	Current
59630-115	Keflex	cephalexin	Shionogi Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73638	SUPPL	2023-03-01
56961	SUPPL	2018-12-21
56959	SUPPL	2018-12-21
56903	SUPPL	2018-12-20
56901	SUPPL	2018-12-20
38930	SUPPL	2015-11-04
7732	SUPPL	2015-11-04
30012	SUPPL	2008-09-17
30011	SUPPL	2008-05-21
17820	SUPPL	2006-05-16
7731	SUPPL	2006-05-16
7730	SUPPL	2004-12-02
30010	SUPPL	2004-07-01
38929	SUPPL	2004-01-22
30009	SUPPL	2004-01-22