ALENDRONATE SODIUM از شرکت HANGZHOU BINJIANG

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ALENDRONATE SODIUM از شرکت HANGZHOU BINJIANG

Abbreviated New Drug Application (ANDA): 090258

Company: HANGZHOU BINJIANG

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription

AB

No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription

AB

No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription

AB

No No
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE 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
09/24/2009 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
04/18/2017 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

09/26/2012 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/16/2012 SUPPL-4 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

03/29/2013 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ALENDRONATE SODIUM

TABLET;ORAL; EQ 5MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 077982 APOTEX
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 090258 HANGZHOU BINJIANG
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 075710 IMPAX LABS INC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARM

TABLET;ORAL; EQ 10MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 077982 APOTEX
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090124 AUROBINDO PHARMA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090258 HANGZHOU BINJIANG
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 075710 IMPAX LABS INC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARM

TABLET;ORAL; EQ 35MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 077982 APOTEX
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 090124 AUROBINDO PHARMA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 090258 HANGZHOU BINJIANG
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 075710 IMPAX LABS INC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARM
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 076984 WATSON LABS

TABLET;ORAL; EQ 70MG BASE

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 077982 APOTEX
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 090124 AUROBINDO PHARMA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 090258 HANGZHOU BINJIANG
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 075710 IMPAX LABS INC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARM
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 076984 WATSON LABS
FOSAMAX ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription Yes AB 020560 MERCK AND CO INC
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