Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019152
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALAN SR VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
CALAN SR VERAPAMIL HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
CALAN SR VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2019 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019152s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019152Orig1s044ltr.pdf
09/14/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019152Orig1s041ltr.pdf
08/24/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019152Orig1s039ltr.pdf
10/28/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf
01/10/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/01/2011 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf
03/31/2010 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019152s033ltr.pdf
07/01/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019152s032ltr.pdf
11/26/2002 SUPPL-30 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf
02/14/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2001 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/14/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/28/2001 SUPPL-26 Labeling

Label is not available on this site.

12/11/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/16/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/13/1998 SUPPL-23 Labeling

Label is not available on this site.

11/05/1993 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/17/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/23/1992 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/03/1992 SUPPL-17 Labeling

Label is not available on this site.

05/04/1992 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/28/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/06/1991 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/19/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/17/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/14/1989 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/1989 SUPPL-9 Efficacy-New Dosing Regimen

Label is not available on this site.

09/22/1988 SUPPL-8 Labeling

Label is not available on this site.

08/08/1989 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/20/1988 SUPPL-5 Labeling

Label is not available on this site.

11/30/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/30/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/24/1987 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/28/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019152s044lbl.pdf
09/14/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf
08/24/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf
10/28/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf
12/01/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf
03/31/2010 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf
07/01/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf

CALAN SR

TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALAN SR VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019152 PFIZER
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206173 CADILA PHARMS LTD
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078906 GLENMARK GENERICS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 073568 IVAX SUB TEVA PHARMS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074587 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075072 PAR PHARM
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090529 SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALAN SR VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019152 PFIZER
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090700 GLENMARK GENERICS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 073568 IVAX SUB TEVA PHARMS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074587 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075072 PAR PHARM
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090529 SUN PHARM INDS INC

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