Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071858
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription AB No Yes
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription AB No No
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG 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
07/17/1987 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
10/27/2010 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

01/14/2010 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/02/2004 SUPPL-14 Labeling

Label is not available on this site.

12/01/2003 SUPPL-13 Labeling

Label is not available on this site.

02/25/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/17/1993 SUPPL-8 Labeling

Label is not available on this site.

08/11/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/05/1991 SUPPL-6 Labeling

Label is not available on this site.

01/31/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/13/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLORAZEPATE DIPOTASSIUM

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 071789 ALRA

TABLET;ORAL; 3.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 071787 ALRA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 071788 ALRA
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription Yes AB 017105 RECORDATI RARE

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