Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020943
Company: RECRO GAINESVILLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERELAN PM VERAPAMIL HYDROCHLORIDE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN PM VERAPAMIL HYDROCHLORIDE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN PM VERAPAMIL HYDROCHLORIDE 300MG 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
11/25/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20943lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20943ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-943_VerelanPM.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020943s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020943Orig1s035ltr.pdf
11/18/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020943s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020943Orig1s032ltr.pdf
10/14/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020943s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020943Orig1s029ltr.pdf
11/14/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020943s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020943s028ltr.pdf
04/01/2010 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf
12/16/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020943s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020943s021ltr.pdf
05/01/2007 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020943s020ltr.pdf
05/05/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20943slr013_verapamil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20943slr013ltr.pdf
12/26/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf
11/29/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/13/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/04/1999 SUPPL-2 Labeling

Label is not available on this site.

07/02/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/03/2019 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020943s035lbl.pdf
11/18/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020943s032lbl.pdf
10/14/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020943s029lbl.pdf
11/14/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020943s028lbl.pdf
04/01/2010 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf
04/01/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020943s007s026.pdf
12/16/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020943s021lbl.pdf
05/05/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20943slr013_verapamil_lbl.pdf
11/25/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20943lbl.pdf

VERELAN PM

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078306 MYLAN
VERELAN PM VERAPAMIL HYDROCHLORIDE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020943 RECRO GAINESVILLE

CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078306 MYLAN
VERELAN PM VERAPAMIL HYDROCHLORIDE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020943 RECRO GAINESVILLE

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