Application 076981

Type: ANDA
Sponsor: ALPHAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESCITALOPRAM	ESCITALOPRAM OXALATE	TABLET; ORAL	5MG	No	No
002	ESCITALOPRAM	ESCITALOPRAM OXALATE	TABLET; ORAL	10MG	No	No
003	ESCITALOPRAM	ESCITALOPRAM OXALATE	TABLET; ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM	Proficient Rx LP	2fb28a40-037a-49a0-b418-6c6841885cf4	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram
Escitalopram	ESCITALOPRAM OXALATE	Proficient Rx LP	2d0b4839-e4d1-4e0e-9dc0-ba821f266472	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	85b2f57e-53f3-4b93-9128-ad74cc34be4c	2020-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram
escitalopram oxalate	ESCITALOPRAM OXALATE	Proficient Rx LP	e773030f-d07d-4bb8-9dc9-6f649688346d	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE

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
8988	ORIG	2006-06-06