Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077686
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET, 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
03/15/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2016 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/21/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 420MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

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