Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019614
Company: RECRO GAINESVILLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERELAN VERAPAMIL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
05/29/1990 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
10/01/2019 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019614s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019614Orig1s056ltr.pdf
11/18/2016 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019614Orig1s053ltr.pdf
10/09/2014 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019614Orig1s050ltr.pdf
11/14/2011 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019614s049ltr.pdf
03/30/2010 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf
03/30/2010 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf
11/29/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/13/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/05/1999 SUPPL-27 Labeling

Label is not available on this site.

10/15/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/29/1997 SUPPL-25 Labeling

Label is not available on this site.

07/14/1998 SUPPL-24 Labeling

Label is not available on this site.

12/30/1997 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/16/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/01/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/02/1995 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/10/1996 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/08/1993 SUPPL-12 Labeling

Label is not available on this site.

06/21/1995 SUPPL-11 Labeling

Label is not available on this site.

03/30/1994 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/1993 SUPPL-9 Labeling

Label is not available on this site.

10/02/1992 SUPPL-8 Labeling

Label is not available on this site.

10/02/1992 SUPPL-7 Labeling

Label is not available on this site.

10/12/1994 SUPPL-6 Labeling

Label is not available on this site.

09/13/1991 SUPPL-5 Labeling

Label is not available on this site.

06/06/1991 SUPPL-4 Labeling

Label is not available on this site.

01/09/1992 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/18/1994 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/05/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/01/2019 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019614s056lbl.pdf
11/18/2016 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf
10/09/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf
11/14/2011 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf
03/30/2010 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf

VERELAN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 075138 MYLAN
VERELAN VERAPAMIL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 019614 RECRO GAINESVILLE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 075138 MYLAN
VERELAN VERAPAMIL HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 019614 RECRO GAINESVILLE

CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 075138 MYLAN
VERELAN VERAPAMIL HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 019614 RECRO GAINESVILLE

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