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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074174
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription AB No No
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
10/19/1993 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
09/20/2021 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/31/2019 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/08/2007 SUPPL-4 Labeling

Label is not available on this site.

04/30/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/27/1997 SUPPL-1 Labeling

Label is not available on this site.

ALPRAZOLAM

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 207507 BRECKENRIDGE
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 200739 NATCO
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074174 NOVITIUM PHARMA
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 090248 STRIDES PHARMA
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 090082 SUN PHARM
XANAX ALPRAZOLAM 0.25MG TABLET;ORAL Prescription Yes AB 018276 UPJOHN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 207507 BRECKENRIDGE
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 200739 NATCO
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074174 NOVITIUM PHARMA
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 090248 STRIDES PHARMA
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 090082 SUN PHARM
XANAX ALPRAZOLAM 0.5MG TABLET;ORAL Prescription Yes AB 018276 UPJOHN

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 207507 BRECKENRIDGE
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 200739 NATCO
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074174 NOVITIUM PHARMA
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 090248 STRIDES PHARMA
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 090082 SUN PHARM
XANAX ALPRAZOLAM 1MG TABLET;ORAL Prescription Yes AB 018276 UPJOHN

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 BRECKENRIDGE
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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