Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207849
Company: XIROMED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription AB No No
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
MIDODRINE HYDROCHLORIDE 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
10/01/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

MIDODRINE HYDROCHLORIDE

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 PHARMS LTD
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 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
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
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 PHARMS LTD
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 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
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207849 XIROMED
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 213055 ZYDUS
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 PHARMS LTD
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 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
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207849 XIROMED
MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 213055 ZYDUS
ORVATEN MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076725 UPSHER SMITH LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English