Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075401
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAZTIA XT DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
TAZTIA XT DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
TAZTIA XT DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
TAZTIA XT DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 No No
TAZTIA XT 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
04/10/2003 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75401TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075401.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2011 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/29/2008 SUPPL-11 Labeling

Label is not available on this site.

TAZTIA XT

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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