Application 208443

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIDAXOMICIN	FIDAXOMICIN	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208443-001	FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET / ORAL	AB		2024-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208443-001	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
2026-09-14 22:38:34	2026-08	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL		2024-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208443-001	FIDAXOMICIN	200MG	TABLET / ORAL	AB	2024-01-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208443-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208443-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208443-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208443-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208443-001	AB	1	`6a471c1ec25d…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208443-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208443-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208443-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208443-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208443-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208443-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fidaxomicin	FIDAXOMICIN	Sandoz Inc	5e8ad2f1-a227-4171-9b66-cd6ce49b8baa	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Fidaxomicin generic name: FIDAXOMICIN
Fidaxomicin	FIDAXOMICIN	Apotex Corp.	6cc3e803-8935-f9b3-ab7f-fef8b1c02070	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Fidaxomicin generic name: FIDAXOMICIN
Fidaxomicin	FIDAXOMICIN	Torrent Pharmaceuticals Limited	8f68f0cb-9573-4d5a-8f31-a93dd2706691	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Fidaxomicin generic name: FIDAXOMICIN
Dificid	FIDAXOMICIN	Merck Sharp & Dohme LLC	dd966338-c820-4270-b704-09ef75fa3ceb	2024-10-16	Warnings, Adverse reactions	Name fallback generic name: FIDAXOMICIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77487	ORIG	2024-02-14