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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206387
Company: IPCA LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 40MG 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
06/04/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

ALENDRONATE SODIUM

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 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 206387 IPCA LABS LTD
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 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 206387 IPCA LABS LTD
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 40MG 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 40MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 206387 IPCA LABS LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 40MG 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 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 206387 IPCA LABS LTD
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 ORGANON
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