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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074909
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 2MG 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
03/25/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74909ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2019 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/29/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
10/31/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
02/28/2008 SUPPL-17 Labeling

Label is not available on this site.
12/09/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
04/19/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
11/19/2001 SUPPL-7 Labeling

Label is not available on this site.
10/10/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
02/16/2001 SUPPL-5 Labeling

Label is not available on this site.
02/01/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
11/15/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
08/06/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ALPRAZOLAM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 207507 CHARTWELL RX
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 200739 NATCO
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074174 NOVITIUM PHARMA
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074909 SANDOZ
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 090248 STRIDES PHARMA
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 090082 SUN PHARM
XANAX ALPRAZOLAM 2MG TABLET;ORAL Prescription Yes AB 018276 UPJOHN
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