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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206107
Company: SIGMAPHARM LABS LLC

Products on ANDA 206107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206107Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2026	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206107

ASENAPINE MALEATE

TABLET;SUBLINGUAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206098	ALEMBIC
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	205960	BRECKENRIDGE
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206107	SIGMAPHARM LABS LLC
SAPHRIS	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	Yes	AB	022117	ABBVIE

TABLET;SUBLINGUAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206098	ALEMBIC
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	205960	BRECKENRIDGE
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206107	SIGMAPHARM LABS LLC
SAPHRIS	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	Yes	AB	022117	ABBVIE

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