Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074278
Company: HIKMA

• REMS

Products on ANDA 074278

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	1MG	TABLET;ORAL	Discontinued	None	No	No
LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074278

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74278ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074278.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/22/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/05/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A		Label is not available on this site.
06/18/2018	SUPPL-11		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/074278Orig1s011ltredt.pdf
12/16/2016	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/16/2008	SUPPL-5	Labeling		Label is not available on this site.
04/08/2005	SUPPL-3	Labeling		Label is not available on this site.
09/05/2000	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Therapeutic Equivalents for ANDA 074278

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