Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075138
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB 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
04/20/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-138_Verapamil%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75138ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-138_Verapamil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/27/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/27/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/27/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/12/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/03/2009 SUPPL-11 Labeling

Label is not available on this site.

03/30/2001 SUPPL-3 Labeling

Label is not available on this site.

02/09/2000 SUPPL-2 Labeling

Label is not available on this site.

11/04/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/20/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-138_Verapamil%20Hydrochloride_prntlbl.pdf

VERAPAMIL HYDROCHLORIDE

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; 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

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

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