Application 050640

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTOCILL IN PLASTIC CONTAINER	OXACILLIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	Yes	Yes
002	BACTOCILL IN PLASTIC CONTAINER	OXACILLIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	Yes	Yes

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
N050640-001	BACTOCILL IN PLASTIC CONTAINER	OXACILLIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION		RLD	1989-10-26
N050640-002	BACTOCILL IN PLASTIC CONTAINER	OXACILLIN SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RLD, RS	1989-10-26

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	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050640-001	BACTOCILL IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050640-002	BACTOCILL IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1989-10-26	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	d893e45b-7f18-4c67-b10c-1e2e52a6b3ef	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050640 application number: NDA050640 ndc (product): 0338-1013 ndc (product): 0338-1015

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
0338-1013	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1013	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1013	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1013	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1015	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1015	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1015	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current
0338-1015	OXACILLIN	OXACILLIN	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47442	SUPPL	2017-03-03
47339	SUPPL	2017-02-27
30212	SUPPL	2015-01-08
39066	SUPPL	2015-01-07
17966	SUPPL	2012-11-28
7923	SUPPL	2012-11-23
17965	SUPPL	2011-10-20
7922	SUPPL	2011-10-17
17964	SUPPL	2008-06-05
7921	SUPPL	2008-04-22
30211	SUPPL	2004-03-24
7920	SUPPL	2002-08-23