Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213906
Company: SUN PHARM INDS INC

Products on ANDA 213906

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	AB	No	No
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2024	SUPPL-5	Labeling-Medication Guide, Labeling, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 213906

LEVORPHANOL TARTRATE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	074278	HIKMA
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	212024	SPECGX LLC
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	213906	SUN PHARM INDS INC
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	211484	VIRTUS

TABLET;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET;ORAL	Prescription	No	AB	213906	SUN PHARM INDS INC