FDA.reportPublic FDA data

Application 020401

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGYesNo
002TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGYesNo
003TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGYesNo
004TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGYesNo
005TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL360MGYesNo
006TIAZACDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL420MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-2612TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2612TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2612TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2612TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2613TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2613TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2613TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2613TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2614TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2614TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2614TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2614TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2615TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2615TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2615TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2615TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2616TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2616TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2616TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2616TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2617TIAZACdiltiazem hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2617TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2617TIAZACdiltiazem hydrochlorideBausch Health US LLCNDACurrent
0187-2617TIAZACdiltiazem hydrochlorideBausch Health Americas, Inc.NDACurrent
24658-170Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-170Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-171Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-171Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-172Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-172Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-173Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-173Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-174Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-174Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-346Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
24658-346Diltiazem HydrochlorideDiltiazem HydrochloridePuraCap Laboratories LLCNDA AUTHORIZED GENERICCurrent
43353-888diltiazem hydrochloridediltiazem hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-889diltiazem hydrochloridediltiazem hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-903diltiazem hydrochloridediltiazem hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-906diltiazem hydrochloridediltiazem hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-907diltiazem hydrochloridediltiazem hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
63629-4335diltiazem hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7981Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7981Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7981Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68071-3199Diltiazem Hydrochloridediltiazem hydrochlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3398Diltiazem Hydrochloridediltiazem hydrochlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68151-1480diltiazem hydrochloridediltiazem hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-2111diltiazem hydrochloridediltiazem hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-2112diltiazem hydrochloridediltiazem hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-2113diltiazem hydrochloridediltiazem hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-2114diltiazem hydrochloridediltiazem hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68682-367Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-367Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-367Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-368Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-368Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-368Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-369Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-369Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-369Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-370Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-370Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-370Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-371Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-371Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-371Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-372Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-372Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-372Diltiazem Hydrochloridediltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70518-1009Diltiazem Hydrochloridediltiazem hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1009Diltiazem Hydrochloridediltiazem hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1993Diltiazem Hydrochloridediltiazem hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1993Diltiazem Hydrochloridediltiazem hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71335-0839Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0839Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0839Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0839Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1585Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1585Diltiazem Hydrochloridediltiazem hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82018SUPPL 2025-04-28
81954SUPPL 2025-04-24
45915SUPPL2016-11-22
45939SUPPL2016-11-21
24906SUPPL2010-11-30
34601SUPPL2010-11-22
2476SUPPL2007-07-05
41336SUPPL2001-12-04
20632SUPPL2001-06-06
41335SUPPL1998-01-30