Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090421
Company: SUN PHARM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/15/2010 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
08/24/2012 SUPPL-2 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 SANDOZ
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 090421 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
DILTZAC DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 076395 APOTEX INC
TAZTIA XT DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 075401 ACTAVIS LABS FL INC
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 SANDOZ
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 090421 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
DILTZAC DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 076395 APOTEX INC
TAZTIA XT DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 075401 ACTAVIS LABS FL INC
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 SANDOZ
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 090421 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
DILTZAC DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 076395 APOTEX INC
TAZTIA XT DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 075401 ACTAVIS LABS FL INC
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 SANDOZ
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 090421 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
DILTZAC DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 076395 APOTEX INC
TAZTIA XT DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 075401 ACTAVIS LABS FL INC
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 SANDOZ
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 090421 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 206641 ZYDUS PHARMS
DILTZAC DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 076395 APOTEX INC
TAZTIA XT DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB4 075401 ACTAVIS LABS FL INC
TIAZAC DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB4 020401 BAUSCH

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