Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020401
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIAZAC DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes No
TIAZAC DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes No
TIAZAC DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes No
TIAZAC DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes No
TIAZAC DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes No
TIAZAC DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB4 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/11/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2016 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020401s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020401Orig1s042ltr.pdf
11/20/2015 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/22/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020401s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020401s036ltr.pdf
06/21/2007 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020401s034ltr.pdf
10/03/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/26/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/24/2001 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/29/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/03/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/2000 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20401-s019_tiazac.pdf
02/17/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/13/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/2000 SUPPL-15 Labeling

Label is not available on this site.

02/17/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/16/1998 SUPPL-13 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-401S013_Tiazac.pdf
01/28/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/22/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/30/1998 SUPPL-7 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020401ap.pdf
10/01/1997 SUPPL-6 Labeling

Label is not available on this site.

06/26/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/14/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/16/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/29/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/23/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2016 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020401s042lbl.pdf
11/22/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020401s036lbl.pdf

TIAZAC

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

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 SANDOZ
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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