Drugs@FDA: FDA Approved Drug Products

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

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 077746 APOTEX
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 076577 MYLAN PHARMS INC
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 UNIQUE PHARM LABS
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 077746 APOTEX
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076449 IMPAX PHARMS
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076577 MYLAN PHARMS INC
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 UNIQUE PHARM LABS
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 077746 APOTEX
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076449 IMPAX PHARMS
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076577 MYLAN PHARMS INC
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 UNIQUE PHARM LABS
ORVATEN MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076725 UPSHER SMITH LABS

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