Application 075703

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	SYRUP;ORAL	EQ 0.5MG BASE/5ML	No	No

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
A075703-001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL			2000-11-27

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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075703-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	2000-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075703-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	2000-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075703-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	2000-11-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075703-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	2000-11-27	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	cf8a3449-8bb3-4d5c-8d0d-557590e49ee5	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Clemastine Fumarate generic name: CLEMASTINE FUMARATE
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	5c99e7af-86a5-4c17-82d5-2d4119e4fe72	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: Clemastine Fumarate generic name: CLEMASTINE FUMARATE
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	Chartwell RX, LLC	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	2023-07-07	Warnings, Adverse reactions	Name fallback brand name: CLEMASTINE FUMARATE generic name: CLEMASTINE FUMARATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8769	ORIG	2000-11-27