Application 050655

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	Yes	Yes
002	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050655-001	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION		RLD	1989-10-31
N050655-002	NALLPEN IN PLASTIC CONTAINER	NAFCILLIN SODIUM	EQ 2GM BASE/100ML	INJECTABLE / INJECTION		RLD, RS	1989-10-31

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050655-001	NALLPEN IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050655-002	NALLPEN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1989-10-31	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050655 application number: NDA050655 ndc (product): 0338-1017 ndc (product): 0338-1019

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1017	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1017	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1017	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1017	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1019	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1019	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1019	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1019	NAFCILLIN	NAFCILLIN	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53637	SUPPL	2018-04-09
53628	SUPPL	2018-04-06
49030	SUPPL	2017-07-21
49002	SUPPL	2017-07-17
17974	SUPPL	2015-04-07
30228	SUPPL	2015-04-06
7937	SUPPL	2011-11-14
39075	SUPPL	2011-11-10
39074	SUPPL	2008-04-23
30227	SUPPL	2008-04-16
30226	SUPPL	2006-08-14
30225	SUPPL	2003-08-15
7936	SUPPL	2002-08-23