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 1.

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
2026-02-19 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 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
posaconazole	POSACONAZOLE	Mylan Institutional LLC	1ebbd88b-547b-4b49-ab73-98094a2d5a79	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
posaconazole	POSACONAZOLE	Gland Pharma Limited	52d9d29e-4a37-4926-aa57-8477f5447b34	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Major Pharmaceuticals	8e1e69b8-cf41-47cc-a3ec-1baee55f099a	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
posaconazole	POSACONAZOLE	Hikma Pharmaceuticals USA Inc.	282ddea7-47d8-44e4-8806-169d7cafa951	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Lupin Pharmaceuticals, Inc.	548124ce-8050-46a9-967b-ff23dfb18633	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	ATLANTIC BIOLOGICALS CORP.	dfbc636f-d8a7-4232-a6b0-cda49caadc9b	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Amneal Pharmaceuticals NY LLC	5f795eca-7a03-4c91-9a0e-c1235791b665	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	ENDO USA, Inc.	e031b632-8e57-4359-87bd-a5da02bdc55f	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
NOXAFIL	POSACONAZOLE	Merck Sharp & Dohme LLC	b073b082-7b57-4423-8c06-4fd4263d6f84	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: POSACONAZOLE
posaconazole	POSACONAZOLE	GLENMARK PHARMACEUTICALS INC., USA	a2ba0343-cd17-4b23-8356-005a1dfd0b35	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
posaconazole	POSACONAZOLE	GLENMARK PHARMACEUTICALS INC., USA	91f89a3b-2479-4d05-9997-7b0cfaa496ec	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Dr.Reddys Laboratories Inc	d8d8dd03-46b5-bd26-bb27-7ca31d8c3326	2026-01-25	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Par Health USA, LLC	4032672e-1bb0-427d-a3b3-09cda4beaf34	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	AvKARE	f9c81d88-8e2c-fa53-e053-6394a90ac5c4	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	American Health Packaging	e809a31a-09da-46bf-bcaa-f34b7f3b54a3	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	f15fc7d4-04ea-4be5-bfed-9a8bae74591c	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	42a53b61-be3b-4c69-a3df-d12401dbd0e4	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Posaconazole generic name: POSACONAZOLE
POSACONAZOLE	POSACONAZOLE	Eugia US LLC	2e88e379-b712-4dec-97a2-c90ef3638372	2025-06-07	Warnings, Adverse reactions	Name fallback brand name: POSACONAZOLE generic name: POSACONAZOLE
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