Application 021887

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLI	ORLISTAT	CAPSULE;ORAL	60MG	Yes	Yes

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

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
N021887-001	ALLI	ORLISTAT	60MG	CAPSULE / ORAL		RLD, RS	2007-02-07

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLI	ORLISTAT	Haleon US Holdings LLC	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	2026-03-18	Warnings	Exact identifier application applno (NDA): 021887 application number: NDA021887 ndc (product): 0135-0461
ALLI	ORLISTAT	Aphena Pharma Solutions - Tennessee, LLC	14a75092-f910-53df-e063-6294a90acc66	2024-03-27	Warnings	Exact identifier application applno (NDA): 021887 application number: NDA021887

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0461	ALLI	orlistat	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0461	ALLI	orlistat	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0461	ALLI	orlistat	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85596	SUPPL	2026-03-31
85595	SUPPL	2026-03-31
48401	SUPPL	2017-05-17
48393	SUPPL	2017-05-17
28788	SUPPL	2016-05-27
37831	SUPPL	2016-05-26
16525	SUPPL	2014-08-05
28787	SUPPL	2014-06-18
6391	SUPPL	2011-03-14
6390	SUPPL	2011-02-14
28786	SUPPL	2010-09-27
42339	ORIG	2007-04-10
6389	ORIG	2007-02-12
16524	ORIG	2007-02-08