Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075710
Company: IMPAX LABS INC
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 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
02/06/2008 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/075710Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

07/16/2015 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/16/2015 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/22/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/15/2013 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/01/2011 SUPPL-8 Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

04/22/2010 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/20/2009 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/23/2009 SUPPL-1 Labeling

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 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 LTD
ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 075710 IMPAX LABS INC
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 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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