Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211745
Company: MICRO LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;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
02/27/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANEXA RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021526 GILEAD
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208862 ACTAVIS ELIZABETH
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210054 AJANTA PHARMA LTD
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210482 ANI PHARMS INC
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210188 CADILA
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211082 GLENMARK PHARMS LTD
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201046 LUPIN LTD
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212284 MANKIND PHARMA
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211745 MICRO LABS
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211829 SCIEGEN PHARMS INC
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211707 SUN PHARM
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211865 SUNSHINE

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANEXA RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021526 GILEAD
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208862 ACTAVIS ELIZABETH
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210054 AJANTA PHARMA LTD
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210482 ANI PHARMS INC
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210188 CADILA
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211082 GLENMARK PHARMS LTD
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201046 LUPIN LTD
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212284 MANKIND PHARMA
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211745 MICRO LABS
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211829 SCIEGEN PHARMS INC
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211707 SUN PHARM
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211865 SUNSHINE

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