Application 091613

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
002	NAFCILLIN SODIUM	NAFCILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091613-001	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26
A091613-002	NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091613-001	AP
A091613-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2012-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091613-001	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091613-002	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2012-12-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A091613-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091613-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091613-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091613-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091613-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091613-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091613-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091613-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091613-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091613-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091613-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091613-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091613-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091613-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091613-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091613-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091613-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091613-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091613-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091613-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091613-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091613-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091613-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091613-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091613-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091613-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091613-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091613-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091613-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091613-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091613-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091613-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091613-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091613-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091613-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091613-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091613-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091613-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091613-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091613-002	AP	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	90717878-64cb-4ffc-90bc-7b4e81e3d1cd	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091613 application number: ANDA091613 ndc (product): 55150-123 ndc (product): 55150-122
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	34821770-929c-40ea-a9e4-d4405dc869e1	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091613 application number: ANDA091613 ndc (product): 55150-123

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-122	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-122	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-122	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current
55150-123	Nafcillin	Nafcillin Sodium	AuroMedics Pharma LLC	ANDA	Current