Application 205053

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOXAFIL	POSACONAZOLE	TABLET, DELAYED RELEASE;ORAL	100MG	Yes	Yes

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
N205053-001	NOXAFIL	POSACONAZOLE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205053-001	ODE-355	2028-06-17
N205053-001	NPP	2029-01-27

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2013-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205053-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205053-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205053-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205053-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205053-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205053-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205053-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205053-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205053-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205053-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205053-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205053-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205053-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205053-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205053-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205053-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205053-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205053-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205053-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205053-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205053-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205053-001	ODE-355	2028-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205053-001	ODE-355	2028-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205053-001	ODE-355	2028-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205053-001	ODE-355	2028-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205053-001	ODE-355	2028-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	NPP	2024-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	I-881	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	ODE-355	2028-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	NPP	2024-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	I-881	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	ODE-355	2028-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	NPP	2024-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	I-881	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	ODE-355	2028-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	NPP	2024-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	I-881	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	ODE-355	2028-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205053-001	NPP	2024-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205053-001	I-881	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205053-001	ODE-355	2028-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	NPP	2024-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	I-881	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	ODE-355	2028-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	NPP	2024-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	I-881	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	ODE-355	2028-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	NPP	2024-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	I-881	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	ODE-355	2028-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	NPP	2024-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205053-001	I-881	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205053-001	ODE-355	2028-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	NPP	2024-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	I-881	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	ODE-355	2028-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	NPP	2024-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205053-001	I-881	2024-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205053-001	ODE-355	2028-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	NPP	2024-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205053-001	I-881	2024-06-17	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSACONAZOLE	POSACONAZOLE	ENDO USA, Inc.	e031b632-8e57-4359-87bd-a5da02bdc55f	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053 ndc (product): 0254-2045
NOXAFIL	POSACONAZOLE	Merck Sharp & Dohme LLC	b073b082-7b57-4423-8c06-4fd4263d6f84	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053 ndc (product): 0085-4324
POSACONAZOLE	POSACONAZOLE	Bryant Ranch Prepack	e2b69c68-8696-4f81-8e2f-e4798116d055	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053 ndc (product): 63629-2236

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme LLC	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme LLC	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0085-4324	NOXAFIL	posaconazole	Merck Sharp & Dohme Corp.	NDA	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-2045	POSACONAZOLE	posaconazole	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
63629-2236	POSACONAZOLE	posaconazole	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2236	POSACONAZOLE	posaconazole	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2236	POSACONAZOLE	posaconazole	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2236	POSACONAZOLE	posaconazole	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2236	POSACONAZOLE	posaconazole	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84862	SUPPL	2026-01-28
84856	SUPPL	2026-01-28
80036	SUPPL	2024-10-29
80025	SUPPL	2024-10-28
69941	SUPPL	2022-01-21
69940	SUPPL	2022-01-21
69885	SUPPL	2022-01-18
69877	SUPPL	2022-01-14
67879	SUPPL	2021-06-23
67858	SUPPL	2021-06-22
67673	SUPPL	2021-06-03
67665	SUPPL	2021-06-02
64610	SUPPL	2020-09-18
64594	SUPPL	2020-09-17
57974	SUPPL	2019-03-12
57971	SUPPL	2019-03-12
57794	SUPPL	2019-02-22
57771	SUPPL	2019-02-22
51008	SUPPL	2018-01-09
50984	SUPPL	2018-01-08
46969	SUPPL	2017-01-24
45296	SUPPL	2016-09-15
40439	SUPPL	2015-11-19
40438	SUPPL	2015-11-19
32622	SUPPL	2015-11-18
32621	SUPPL	2015-11-18
40437	SUPPL	2015-08-19
44912	ORIG	2015-03-16
22972	ORIG	2015-03-16
32620	SUPPL	2014-06-12
32619	ORIG	2013-11-27
40436	ORIG	2013-11-26
51588	ORIG	1900-01-01
51586	ORIG	1900-01-01
51584	ORIG	1900-01-01