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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211454
Company: WINDER LABS LLC

REMS

Products on ANDA 211454

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	20MG/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 211454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2021	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
04/30/2025	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/16/2022	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211454

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; 20MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	20MG/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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