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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211734
Company: MANKIND PHARMA

Products on ANDA 211734

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	AB	No	No
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	AB	No	No
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211734

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211734Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 211734

APREMILAST

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	10MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	20MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	30MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

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