Application 021990

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002EXFORGEAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;160MGYesNo
003EXFORGEAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;160MGYesYes
004EXFORGEAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;320MGYesNo
005EXFORGEAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;320MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021990-002EXFORGEAMLODIPINE BESYLATE; VALSARTANEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-20
N021990-003EXFORGEAMLODIPINE BESYLATE; VALSARTANEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-20
N021990-004EXFORGEAMLODIPINE BESYLATE; VALSARTANEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-20
N021990-005EXFORGEAMLODIPINE BESYLATE; VALSARTANEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021990-002AB
N021990-003AB
N021990-004AB
N021990-005AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-2084e616aacf4f…
2026-08-18 06:07:402026-07N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021990-002EXFORGEEQ 5MG BASE;160MGTABLET / ORALABRLD2007-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021990-003EXFORGEEQ 10MG BASE;160MGTABLET / ORALABRLD, RS2007-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021990-004EXFORGEEQ 5MG BASE;320MGTABLET / ORALABRLD2007-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021990-005EXFORGEEQ 10MG BASE;320MGTABLET / ORALABRLD, RS2007-06-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021990-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021990-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021990-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021990-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021990-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021990-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021990-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021990-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021990-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021990-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021990-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021990-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021990-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021990-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021990-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021990-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021990-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021990-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021990-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021990-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021990-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021990-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021990-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021990-005AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021990-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021990-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021990-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021990-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021990-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021990-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021990-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021990-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021990-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021990-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021990-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021990-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021990-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-005AB174a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021990-00263957282019-07-08Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-00363957282019-07-08Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-00463957282019-07-08Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021990-00563957282019-07-08Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021990-00263957282019-07-08Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021990-00363957282019-07-08Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021990-00463957282019-07-08Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021990-00563957282019-07-08Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021990-00263957282019-07-08Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021990-00363957282019-07-08Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021990-00463957282019-07-08Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021990-00563957282019-07-08Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021990-00263957282019-07-08Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021990-00363957282019-07-08Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021990-00463957282019-07-08Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021990-00563957282019-07-08Drug productea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ExforgeAMLODIPINE BESYLATE AND VALSARTANNovartis Pharmaceuticals Corporationd0caec89-96ec-411d-a933-63eda74a6da72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021990
application number: NDA021990
ndc (product): 0078-0489
ndc (product): 0078-0488
ndc (product): 0078-0490
ndc (product): 0078-0491

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0488Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0489Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0490Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0078-0491Exforgeamlodipine besylate and valsartanNovartis Pharmaceuticals CorporationNDACurrent
0781-5615AMLODIPINE AND VALSARTANamlodipine besylate and valsartanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5628AMLODIPINE AND VALSARTANamlodipine besylate and valsartanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5639AMLODIPINE AND VALSARTANamlodipine besylate and valsartanSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5643AMLODIPINE AND VALSARTANamlodipine besylate and valsartanSandoz IncNDA AUTHORIZED GENERICCurrent
50090-2471AMLODIPINE AND VALSARTANamlodipine besylate and valsartanA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73304SUPPL2023-01-27
67008SUPPL2021-04-08
59064SUPPL2019-06-13
59059SUPPL2019-06-13
48427SUPPL2017-05-17
16702SUPPL2015-07-30
6606SUPPL2015-07-30
16701SUPPL2014-09-26
6605SUPPL2014-09-25
38011SUPPL2014-03-19
28992SUPPL2014-03-19
6604SUPPL2014-03-19
16700SUPPL2012-12-10
28991SUPPL2012-11-29
28990SUPPL2012-10-02
38010SUPPL2012-10-01
38009SUPPL2012-01-30
6603SUPPL2012-01-20
28989SUPPL2011-12-14
16699SUPPL2011-12-13
6602SUPPL2011-11-02
38008SUPPL2011-10-31
16698SUPPL2011-06-07
28988SUPPL2011-06-03
6601SUPPL2010-04-05
38007SUPPL2010-04-04
42370ORIG2008-10-03
6600SUPPL2008-07-25
38006SUPPL2008-07-24
6599ORIG2007-07-05
38005ORIG2007-06-25
6598ORIG2007-01-08