Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078306
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078306ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/01/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/01/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

07/31/2010 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

VERAPAMIL HYDROCHLORIDE

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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