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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203518
Company: TRIS PHARMA INC

REMS

Products on ANDA 203518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203518Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-17	REMS - MODIFIED - D-N-A		Label is not available on this site.
09/18/2018	SUPPL-4	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 203518

MORPHINE SULFATE

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206573	PHARM ASSOC
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	203518	TRIS PHARMA INC
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211454	WINDER LABS LLC

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	201574	PADAGIS US
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206573	PHARM ASSOC
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	202348	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	203518	TRIS PHARMA INC
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211454	WINDER LABS LLC

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