Application 062755

Type: ANDA
Sponsor: GLAXOSMITHKLINE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062755-001	NALLPEN	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1986-12-19
A062755-002	NALLPEN	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			1986-12-19

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062755-001	NALLPEN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062755-002	NALLPEN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	1986-12-19	`f41ea6bd6efb…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nafcillin	NAFCILLIN SODIUM	Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.	8a00624c-c436-4102-a042-dab54022bcc2	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
NAFCILLIN SODIUM	NAFCILLIN SODIUM	ONESOURCE SPECIALTY PHARMA LIMITED	4b3b8e52-df96-4886-e063-6294a90ac63f	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
NAFCILLIN SODIUM	NAFCILLIN SODIUM	Armas Pharmaceuticals Inc.	090fda61-b9c8-640e-e063-6294a90a7363	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	90717878-64cb-4ffc-90bc-7b4e81e3d1cd	2025-08-16	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	8ec288e6-4d7f-4fea-a5ab-f9f337ebaa86	2025-08-16	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	34821770-929c-40ea-a9e4-d4405dc869e1	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Eugia US LLC	0f21384c-0f82-4d99-a05c-6773d1ee4bcf	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Avenacy Inc.	0556378a-b794-4235-ba09-ebdc295e9092	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	NorthStar Rx, LLC	ae5fb012-4012-4063-b2e4-f1f927c6bf74	2024-07-09	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Fresenius Kabi USA, LLC	3c2581a1-8051-4d7a-a1f7-521248648dc9	2019-05-24	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM
Nafcillin	NAFCILLIN SODIUM	Fresenius Kabi USA, LLC	c39721a3-7b22-4720-9dbd-bc82f03d2af7	2019-05-17	Warnings, Adverse reactions	Name fallback generic name: NAFCILLIN SODIUM

Reported adverse events (FAERS/openFDA)#

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