Application 062206

Type: ANDA
Sponsor: FACTA FARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFACLOR	CEFACLOR	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No
002	CEFACLOR	CEFACLOR	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	No	No
003	CEFACLOR	CEFACLOR	FOR SUSPENSION;ORAL	EQ 187MG BASE/5ML	No	No
004	CEFACLOR	CEFACLOR	FOR SUSPENSION;ORAL	EQ 375MG BASE/5ML	No	No

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
A062206-001	CEFACLOR	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982
A062206-002	CEFACLOR	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982
A062206-003	CEFACLOR	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20
A062206-004	CEFACLOR	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20

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 2 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062206-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062206-002	CEFACLOR	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062206-003	CEFACLOR	EQ 187MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062206-004	CEFACLOR	EQ 375MG BASE/5ML	FOR SUSPENSION / ORAL		1988-04-20	`4b0b4de00fa7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefaclor	CEFACLOR	Carlsbad Technology, Inc.	2f61354e-bcb0-41aa-955f-51eabc11387b	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	A-S Medication Solutions	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	Azorian Pharma, LLC	224af904-38f3-4210-a750-e21006db4c66	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	Teva Pharmaceuticals USA, Inc.	0878bdc2-0410-4938-9890-96523aa81c2f	2019-07-31	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR

Reported adverse events (FAERS/openFDA)#

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