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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204393
Company: PIRAMAL CRITICAL

Products on ANDA 204393

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITIGO	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
MITIGO	MORPHINE SULFATE	25MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204393Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2025	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/06/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204393

MITIGO

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INFUMORPH	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MITIGO	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204393	PIRAMAL CRITICAL
MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205758	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211452	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	202515	HOSPIRA INC

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INFUMORPH	MORPHINE SULFATE	25MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MITIGO	MORPHINE SULFATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204393	PIRAMAL CRITICAL

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