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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076725
Company: UPSHER SMITH LABS

Products on ANDA 076725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORVATEN	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
ORVATEN	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	Yes
ORVATEN	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/03/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
05/05/2005	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076725

ORVATEN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	214734	ALEMBIC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	077746	APOTEX
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	212774	AUROBINDO PHARMA LTD
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	076449	IMPAX PHARMS
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	217271	MANKIND PHARMA
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	076577	MYLAN PHARMS INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	211973	NOVUGEN
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	207169	PAR PHARM INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	212543	RUBICON
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	207613	THINQ PHARM-CRO PVT
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	207849	XIROMED
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	213055	ZYDUS LIFESCIENCES
ORVATEN	MIDODRINE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	076725	UPSHER SMITH LABS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	214734	ALEMBIC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	077746	APOTEX
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212774	AUROBINDO PHARMA LTD
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076449	IMPAX PHARMS
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	217271	MANKIND PHARMA
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076577	MYLAN PHARMS INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	211973	NOVUGEN
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207169	PAR PHARM INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212543	RUBICON
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207613	THINQ PHARM-CRO PVT
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207849	XIROMED
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	213055	ZYDUS LIFESCIENCES
ORVATEN	MIDODRINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076725	UPSHER SMITH LABS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	214734	ALEMBIC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	077746	APOTEX
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	212774	AUROBINDO PHARMA LTD
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076449	IMPAX PHARMS
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	217271	MANKIND PHARMA
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076577	MYLAN PHARMS INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	211973	NOVUGEN
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207169	PAR PHARM INC
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	212543	RUBICON
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207613	THINQ PHARM-CRO PVT
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207849	XIROMED
MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	213055	ZYDUS LIFESCIENCES
ORVATEN	MIDODRINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076725	UPSHER SMITH LABS

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