Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213479
Company: NOVITIUM PHARMA

• REMS

Products on ANDA 213479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET;ORAL	Prescription	BX	No	No
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET;ORAL	Prescription	BX	No	No
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	1MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2020	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
12/22/2025	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/12/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-17	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 213479

LEVORPHANOL TARTRATE

There are no Therapeutic Equivalents.