Application 019787

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASEYesNo
002NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASEYesNo
003NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019787-001NORVASCAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALABRLD1992-07-31
N019787-002NORVASCAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALABRLD1992-07-31
N019787-003NORVASCAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019787-001AB
N019787-002AB
N019787-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-002NORVASCEQ 5MG BASETABLET / ORALABRLD1992-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-003NORVASCEQ 10MG BASETABLET / ORALABRLD, RS1992-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019787-001NORVASCEQ 2.5MG BASETABLET / ORALABRLD1992-07-311e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019787-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019787-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019787-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019787-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019787-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019787-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019787-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019787-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019787-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019787-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019787-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019787-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019787-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019787-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019787-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019787-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019787-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019787-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019787-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019787-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019787-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019787-001AB11e350fbaab3a…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amlodipine besylateAMLODIPINE BESYLATEMylan Pharmaceuticals Inc.180ee374-24f2-4b9c-9d54-8815f2b1dc9b2024-11-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 019787
application number: NDA019787
ndc (product): 59762-2135
ndc (product): 59762-2010
ndc (product): 59762-2242
NorvascAMLODIPINE BESYLATEViatris Specialty LLC7367289c-b0b0-466a-83e2-558e2985c29f2023-02-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019787
application number: NDA019787
amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCf3482709-c5c3-4bd0-8067-ad57f31bb5252022-10-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019787
application number: NDA019787
ndc (product): 71610-469
NorvascAMLODIPINE BESYLATEPFIZER LABORATORIES DIV PFIZER INCabd6a2ca-40c2-485c-bc53-db1c652505ed2019-01-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019787
application number: NDA019787
ndc (product): 0069-1540
ndc (product): 0069-1520
ndc (product): 0069-1530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-1520Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1520Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1530Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1530Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1540Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1540Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
21695-151Norvascamlodipine besylateRebel Distributors CorpNDACurrent
55154-0535amlodipine besylateamlodipine besylateCardinal HealthNDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
67046-020amlodipine besylateamlodipine besylateContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67296-0672amlodipine besylateamlodipine besylateRedPharm Drug Inc.NDA AUTHORIZED GENERICCurrent
67296-0673amlodipine besylateamlodipine besylateRedPharm Drug Inc.NDA AUTHORIZED GENERICCurrent
69189-1540amlodipine besylateamlodipine besylateAvera McKennan HospitalNDA AUTHORIZED GENERICCurrent
71610-469amlodipine besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-469amlodipine besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50438SUPPL2017-11-17
50296SUPPL2017-11-06
47825SUPPL2017-04-03
47800SUPPL2017-03-31
11721SUPPL2015-04-09
19224SUPPL2015-03-25
19223SUPPL2013-01-08
19222SUPPL2013-01-08
11720SUPPL2013-01-07
11719SUPPL2013-01-07
19221SUPPL2011-11-02
11718SUPPL2011-10-31
1623SUPPL2011-05-11
33954SUPPL2011-05-09
33953SUPPL2010-02-23
19220SUPPL2010-02-22
1622SUPPL2007-11-08
11717SUPPL2007-11-07
41035SUPPL2007-03-02
19219SUPPL2005-10-20
33952SUPPL2005-09-30
33951SUPPL2005-07-15
1621SUPPL2005-07-15
1617SUPPL2004-06-10
1619SUPPL2004-01-09
19217SUPPL2003-12-08
1620SUPPL2003-08-28
41032SUPPL2003-08-05
41031SUPPL2003-08-05
41030SUPPL2003-08-05
41029SUPPL2003-08-05
41028SUPPL2003-08-05
41026SUPPL2003-08-05
41025SUPPL2003-08-05
41024SUPPL2003-08-05
20358SUPPL2003-08-05
20356SUPPL2003-08-05
20354SUPPL2003-08-05
20353SUPPL2003-08-05
20352SUPPL2003-08-05
20351SUPPL2003-08-05
19218SUPPL2002-05-28
41027SUPPL2002-04-30
41034SUPPL2000-07-12
20357SUPPL2000-07-12
1618SUPPL2000-07-12
1616SUPPL2000-07-12
20359SUPPL2000-02-01
20360SUPPL1999-12-15
41033SUPPL1999-06-04
20355SUPPL1997-01-08