Application 207355

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POSACONAZOLE	POSACONAZOLE	TABLET, DELAYED RELEASE;ORAL	100MG	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
A207355-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL			2022-11-30

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	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-11-30	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207355-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL		2022-11-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A207355-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207355-001	AB	1	`3bdfa0b2c4d7…`

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Posaconazole	POSACONAZOLE	A2A Integrated Pharmaceuticals	4d14ceab-196e-4dc3-8b21-5c4629ada161	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Golden State Medical Supply, Inc.	e883b495-d7e7-6d58-e053-2a95a90a1cd3	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Camber Pharmaceuticals, Inc.	c551e121-d5fc-4b35-ba9f-72ce3a314fdc	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	AvPAK	de95df83-a495-1900-e053-2995a90abf24	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Lannett Company Inc.	94a9b028-a2bc-4f41-884d-2d6c536881fc	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	i3 Pharmaceuticals, LLC	d5300d14-219d-4e1e-bfac-b413c40d6e3a	2024-11-29	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
posaconazole	POSACONAZOLE	Novadoz Pharmaceuticals LLC	0bdf77ae-3639-49c1-b7c7-533f9d073084	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	d2daba09-f1c2-4764-a567-1291be4892b9	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Fresensius Kabi USA, LLC	86be8cdb-c991-4754-b8f4-1ab79ac40bda	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE DELAYED-RELEASE	Chartwell RX, LLC	f2baa339-75ff-4c03-8334-a88648f701f7	2022-12-20	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Camber Pharmaceuticals, Inc.	573d89eb-05d8-4035-b406-6409f36ab707	2022-12-17	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	NorthStar RxLLC	4de6d839-e4bd-405c-83c5-8efc6abd0829	2022-12-17	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Biocon Phama Inc.	e0e8023a-3c82-e455-a57b-ccc0206ad156	2022-04-27	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE

Reported adverse events (FAERS/openFDA)#

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