CARDIZEM از شرکت BAUSCH

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CARDIZEM از شرکت BAUSCH

New Drug Application (NDA): 018602

Company: BAUSCH

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CARDIZEMDILTIAZEM HYDROCHLORIDE30MGTABLET;ORALPrescription

AB

YesNo
CARDIZEMDILTIAZEM HYDROCHLORIDE60MGTABLET;ORALPrescription

AB

YesNo
CARDIZEMDILTIAZEM HYDROCHLORIDE90MGTABLET;ORALPrescription

AB

YesNo
CARDIZEMDILTIAZEM HYDROCHLORIDE120MGTABLET;ORALPrescription

AB

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
11/05/1982ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
06/29/2020SUPPL-69 Manufacturing (CMC)-Packaging

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018602Orig1s069lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018602Orig1s069ltr.pdf

11/18/2016SUPPL-67 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018602s067lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018602Orig1s067ltr.pdf

11/21/2014SUPPL-65 Labeling-Package Insert

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf

06/24/2014SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

11/23/2010SUPPL-63 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018602s063ltr.pdf

06/04/2001SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1999SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2003SUPPL-56 Labeling

Label is not available on this site.

02/05/1998SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

11/19/1997SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1997SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1996SUPPL-51 Labeling

Label is not available on this site.

04/02/1996SUPPL-50 Labeling

Label is not available on this site.

08/29/1995SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1994SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1994SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1995SUPPL-46 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/21/1994SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/28/1994SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/1993SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/08/1993SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1993SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1994SUPPL-40 Labeling

Label is not available on this site.

05/27/1992SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1991SUPPL-38 Labeling

Label is not available on this site.

03/14/1991SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/18/1989SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/1989SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1990SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1988SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1988SUPPL-32 Labeling

Label is not available on this site.

08/12/1988SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1988SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/19/1988SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/30/1987SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/07/1987SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987SUPPL-25 Labeling

Label is not available on this site.

07/01/1993SUPPL-23 Efficacy-New Indication

Label is not available on this site.

07/28/1986SUPPL-22 Labeling

Label is not available on this site.

12/08/1986SUPPL-20 Efficacy-New Patient Population

Label is not available on this site.

06/20/1985SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1985SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1986SUPPL-11 Efficacy-New Dosing Regimen

Label is not available on this site.

06/08/1984SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1984SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/08/1984SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1983SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/06/1983SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1983SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1983SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/27/1983SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1983SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1983SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/29/2020SUPPL-69

Manufacturing (CMC)-Packaging

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018602Orig1s069lbl.pdf
11/18/2016SUPPL-67

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018602s067lbl.pdf
11/21/2014SUPPL-65

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf
11/23/2010SUPPL-63

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf

CARDIZEM

TABLET;ORAL; 30MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARDIZEMDILTIAZEM HYDROCHLORIDE30MGTABLET;ORALPrescriptionYesAB018602BAUSCH
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET;ORALPrescriptionNoAB211596EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET;ORALPrescriptionNoAB074185TEVA

TABLET;ORAL; 60MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARDIZEMDILTIAZEM HYDROCHLORIDE60MGTABLET;ORALPrescriptionYesAB018602BAUSCH
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET;ORALPrescriptionNoAB211596EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET;ORALPrescriptionNoAB074185TEVA

TABLET;ORAL; 90MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARDIZEMDILTIAZEM HYDROCHLORIDE90MGTABLET;ORALPrescriptionYesAB018602BAUSCH
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET;ORALPrescriptionNoAB211596EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET;ORALPrescriptionNoAB074185TEVA

TABLET;ORAL; 120MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARDIZEMDILTIAZEM HYDROCHLORIDE120MGTABLET;ORALPrescriptionYesAB018602BAUSCH
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET;ORALPrescriptionNoAB211596EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET;ORALPrescriptionNoAB074185TEVA
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