Application 020838

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATACANDCANDESARTAN CILEXETILTABLET;ORAL4MGYesNo
002ATACANDCANDESARTAN CILEXETILTABLET;ORAL8MGYesNo
003ATACANDCANDESARTAN CILEXETILTABLET;ORAL16MGYesNo
004ATACANDCANDESARTAN CILEXETILTABLET;ORAL32MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020838-001ATACANDCANDESARTAN CILEXETIL4MGTABLET / ORALABRLD1998-06-04
N020838-002ATACANDCANDESARTAN CILEXETIL8MGTABLET / ORALABRLD1998-06-04
N020838-003ATACANDCANDESARTAN CILEXETIL16MGTABLET / ORALABRLD1998-06-04
N020838-004ATACANDCANDESARTAN CILEXETIL32MGTABLET / ORALABRLD, RS1998-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020838-001AB
N020838-002AB
N020838-003AB
N020838-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020838-001ATACAND4MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-002ATACAND8MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-003ATACAND16MGTABLET / ORALABRLD1998-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-004ATACAND32MGTABLET / ORALABRLD, RS1998-06-04d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020838-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020838-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020838-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020838-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020838-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020838-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020838-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020838-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020838-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020838-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020838-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020838-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020838-004AB1d06236e962d9…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candesartan cilexetilCANDESARTAN CILEXETILGolden State Medical Supply, Inc.15601654-76da-04cf-e063-6394a90a2cb52026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838
ATACANDCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.94a59260-d2b6-464a-b5b9-bbc599e57e102025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838
ndc (product): 62559-642
ndc (product): 62559-641
ndc (product): 62559-640
ndc (product): 62559-643
Candesartan cilexetilCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.4621249c-1f44-4d95-8513-a1a2b1859e412025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020838
application number: NDA020838

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0004ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0008ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0016ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0032ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3376ATACANDCandesartan cilexetilBryant Ranch PrepackNDACurrent
63629-3376ATACANDCandesartan cilexetilBryant Ranch PrepackNDACurrent
68151-4145ATACANDCandesartan cilexetilCarilion Materials ManagementNDACurrent
68151-4146ATACANDCandesartan cilexetilCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63699SUPPL2020-06-25
63695SUPPL2020-06-25
13577SUPPL2016-02-11
3529SUPPL2016-02-11
26017SUPPL2015-02-10
13576SUPPL2015-02-09
26018SUPPL2013-04-30
35485SUPPL2013-04-29
3528SUPPL2012-05-02
35484SUPPL2012-05-01
13575SUPPL2012-04-17
3527SUPPL2012-04-16
44075ORIG2011-12-22
26016SUPPL2011-07-05
35483SUPPL2011-06-28
26015SUPPL2009-11-05
35482SUPPL2009-10-23
51279SUPPL2007-01-30
35481SUPPL2006-08-21
3526SUPPL2006-08-21
13573SUPPL2005-05-20
3524SUPPL2005-05-20
51278SUPPL2005-03-15
26014SUPPL2005-02-23
13574SUPPL2005-02-23
3525SUPPL2004-12-30
51277SUPPL2004-08-27
41744SUPPL2004-05-27
26013SUPPL2004-05-27
21001SUPPL2004-05-27
51275SUPPL2003-11-02
3523SUPPL2003-05-29
21000ORIG2003-05-22
51276SUPPL2003-01-08
35480SUPPL2002-09-13
26012SUPPL2002-09-13
51274SUPPL1999-03-15
35479ORIG1998-06-04
26011ORIG1998-06-04
63880ORIG1900-01-01
63879ORIG1900-01-01
63878ORIG1900-01-01
63877ORIG1900-01-01
63876ORIG1900-01-01
63875ORIG1900-01-01
54099ORIG1900-01-01
54098ORIG1900-01-01
54097ORIG1900-01-01