Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090022
Company: SUN PHARMA GLOBAL
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
09/10/2008 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
04/08/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/07/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/28/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/01/2011 SUPPL-6 REMS-Proposal

Label is not available on this site.

04/05/2011 SUPPL-5 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/29/2010 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

11/17/2009 SUPPL-2 Labeling-Container/Carton Labels

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 090258 AUSTARPHARMA LLC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 079049 DR REDDYS LABS LTD
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 090557 JUBILANT CADISTA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 076584 MYLAN
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARMA GLOBAL

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 090258 AUSTARPHARMA LLC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 079049 DR REDDYS LABS LTD
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 090557 JUBILANT CADISTA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 076584 MYLAN
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARMA GLOBAL

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 090258 AUSTARPHARMA LLC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 079049 DR REDDYS LABS LTD
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 090557 JUBILANT CADISTA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 076584 MYLAN
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARMA GLOBAL
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 090258 AUSTARPHARMA LLC
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 076768 CIPLA LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 079049 DR REDDYS LABS LTD
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 090557 JUBILANT CADISTA
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 076584 MYLAN
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET;ORAL Prescription No AB 090022 SUN PHARMA GLOBAL
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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