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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211484
Company: ACERTIS PHARMS

REMS

Products on ANDA 211484

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211484

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211484Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-11	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/22/2025	SUPPL-9	Labeling-Patient Package Insert		Label is not available on this site.
12/15/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/01/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211484

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	211484	ACERTIS PHARMS
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

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