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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211652
Company: LUPIN PHARMS

Products on ANDA 211652

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	AB	No	No
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	AB	No	No
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211652

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211652Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211652

DROXIDOPA

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214391	AJANTA PHARMA LTD
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	212835	HIKMA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211652	LUPIN PHARMS
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS INC
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	215265	SLATE RUN PHARMA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214543	TRIS PHARMA INC
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	213661	UPSHER SMITH LABS
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214391	AJANTA PHARMA LTD
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	212835	HIKMA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211652	LUPIN PHARMS
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS INC
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	215265	SLATE RUN PHARMA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214543	TRIS PHARMA INC
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	213661	UPSHER SMITH LABS
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214391	AJANTA PHARMA LTD
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	212835	HIKMA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211652	LUPIN PHARMS
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS INC
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	215265	SLATE RUN PHARMA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214543	TRIS PHARMA INC
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	213661	UPSHER SMITH LABS
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

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