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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206641
Company: ZYDUS PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 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
08/11/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206641Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2025 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 420MG
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 091022 CHARTWELL RX
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
TIAZAC DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH
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