Application 050114

Type: NDA
Sponsor: ALLERQUEST

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRE-PEN	BENZYLPENICILLOYL POLYLYSINE	INJECTABLE;INJECTION	60UMOLAR	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050114-001	PRE-PEN	60UMOLAR	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`

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
PRE-PEN	BENZYLPENICILLOYL POLYLYSINE	ALK-ABELLO, INC.	2fbcc40c-f102-4abe-bce5-a93de95874fe	2024-01-12	Warnings, Adverse reactions	Exact identifier ndc (product): 49471-001

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49471-001	PRE-PEN	benzylpenicilloyl polylysine	AllerQuest LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73250	SUPPL	2023-01-19
73249	SUPPL	2023-01-19
29981	SUPPL	2009-11-09