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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213057
Company: ZYDUS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription AB No No
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription AB No No
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription AB No No
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET;ORAL Prescription AB No No
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG 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
11/20/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ISOSORBIDE DINITRATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISORDIL ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription Yes AB 012093 BAUSCH
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086067 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086923 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 215723 RUBICON
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086221 SANDOZ
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 213057 ZYDUS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086066 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086925 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 215723 RUBICON
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086223 SANDOZ
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 213057 ZYDUS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 088088 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 087537 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 215723 RUBICON
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 089367 SANDOZ
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 213057 ZYDUS

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET;ORAL Prescription No AB 087946 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET;ORAL Prescription No AB 215723 RUBICON
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET;ORAL Prescription No AB 213057 ZYDUS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISORDIL ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription Yes AB 012093 BAUSCH
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription No AB 211290 PAR PHARM INC
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription No AB 215723 RUBICON
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET;ORAL Prescription No AB 213057 ZYDUS
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