Application 090005

Type: ANDA
Sponsor: ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090005-001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090005-001	AP

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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090005-001	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-04-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090005-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090005-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090005-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090005-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090005-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090005-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090005-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090005-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090005-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090005-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090005-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090005-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090005-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090005-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090005-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090005-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090005-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090005-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090005-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090005-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090005-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090005-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090005-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090005-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090005-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090005-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090005-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090005-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090005-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090005-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090005-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090005-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090005-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090005-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090005-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090005-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090005-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090005-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090005-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090005-001	AP	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nafcillin	NAFCILLIN	WG Critical Care, LLC	77999cd2-17b8-4df9-b687-d0f9b62096b9	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005 ndc (product): 44567-223
Nafcillin	NAFCILLIN SODIUM	Sagent Pharmaceuticals	a6a4e122-b7f5-4eb5-8555-7aea6eda794b	2025-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN SODIUM	Avenacy Inc.	0556378a-b794-4235-ba09-ebdc295e9092	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN	NorthStar Rx, LLC	91ebf84a-310f-4271-8446-5a10a877883a	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005
Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a	2019-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090005 application number: ANDA090005 ndc (product): 63323-330

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-223	Nafcillin	NAFCILLIN	WG Critical Care, LLC	ANDA	Current
63323-330	Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-330	Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-330	Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-330	Nafcillin	NAFCILLIN	Fresenius Kabi USA, LLC	ANDA	Current
70860-119	Nafcillin	nafcillin sodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current