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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209920
Company: TEVA PHARMS USA INC

Products on ANDA 209920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	AB	No	No
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209920Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209920

LUBIPROSTONE

CAPSULE;ORAL; 8MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMITIZA	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	Yes	AB	021908	SUCAMPO PHARMA LLC
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	209450	AMNEAL
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	218640	ASCENT PHARMS INC
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	206994	DR REDDYS
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	209920	TEVA PHARMS USA INC
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	214131	ZYDUS PHARMS

CAPSULE;ORAL; 24MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMITIZA	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	Yes	AB	021908	SUCAMPO PHARMA LLC
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	209450	AMNEAL
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	218640	ASCENT PHARMS INC
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	206994	DR REDDYS
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	209920	TEVA PHARMS USA INC
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	214131	ZYDUS PHARMS

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