Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212451
Company: ALKEM LABS LTD

• REMS

Products on ANDA 212451

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	AB	No	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212451

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212451Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212451

MORPHINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	212451	ALKEM LABS LTD
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	Yes	AB	022207	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	215194	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	210610	UPSHER SMITH LABS

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	212451	ALKEM LABS LTD
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	Yes	AB	022207	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	215194	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	210610	UPSHER SMITH LABS