Application 062703

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No
002	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A062703-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13
A062703-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062703-001	AB
A062703-002	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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062703-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062703-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062703-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062703-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062703-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062703-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062703-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062703-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062703-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062703-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062703-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062703-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062703-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062703-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062703-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062703-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062703-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062703-002	AB	1	`bb7c543d1eb4…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	549bf887-1ef6-6a75-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703 ndc (product): 66267-982
Cephalexin	CEPHALEXIN	Proficient Rx LP	febab51b-6b48-488a-8fd1-d24400e5df1d	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703 ndc (product): 63187-205
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	19307ff0-71de-477b-965d-ea243e5ede3a	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703 ndc (product): 0093-4175 ndc (product): 0093-4177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4175	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4177	Cephalexin	Cephalexin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-551	Cephalexin	Cephalexin	Rebel Distributors Corp	ANDA	Current
21695-789	Cephalexin	Cephalexin	Rebel Distributors Corp	ANDA	Current
50090-0218	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0219	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0219	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0220	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0220	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0220	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
53002-2540	Cephalexin	Cephalexin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2540	Cephalexin	Cephalexin	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-205	Cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current
63187-205	Cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current
63187-205	Cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current
66116-607	Cephalexin	Cephalexin	MedVantx, Inc.	ANDA	Current
66267-982	Cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-982	Cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3186	Cephalexin	Cephalexin	NuCarePharmaceuticals, Inc.	ANDA	Current
68071-3186	Cephalexin	Cephalexin	NuCarePharmaceuticals, Inc.	ANDA	Current
68071-3186	Cephalexin	Cephalexin	NuCarePharmaceuticals, Inc.	ANDA	Current
68071-4177	Cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4587	Cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9538	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9538	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9538	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9538	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9538	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9539	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9539	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9539	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9539	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9539	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2077	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current