Application 211672

Type: NDA
Sponsor: NABRIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XENLETA	LEFAMULIN ACETATE	TABLET;ORAL	EQ 600MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211672-001	XENLETA	LEFAMULIN ACETATE	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2019-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17
N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17
N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211672-001	NCE	2024-08-19
N211672-001	GAIN	2029-08-19

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.

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
2026-08-01 22:54:32	2026-06	N211672-001	XENLETA	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2019-08-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N211672-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211672-001	9120727	2031-05-23	Drug substance, Drug product	2019-09-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211672-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N211672-001	NCE	2024-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211672-001	GAIN	2029-08-19	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211672 application number: NDA211672

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72000-110	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-110	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-110	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-110	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-110	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66807	SUPPL	2021-03-18
66799	SUPPL	2021-03-17
64889	SUPPL	2020-10-13
60112	ORIG	2019-09-26
59769	ORIG	2019-08-20
59768	ORIG	2019-08-20