An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020943
Company: SOCIETAL CDMO

Products on NDA 020943

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERELAN PM	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
VERELAN PM	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
VERELAN PM	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020943

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.

Labels for NDA 020943

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

Top