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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075138
Company: MYLAN

Products on ANDA 075138

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075138

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
03/02/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
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.

Labels for ANDA 075138

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

Therapeutic Equivalents for ANDA 075138

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	SOCIETAL CDMO

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	SOCIETAL CDMO

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	SOCIETAL CDMO

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