FDA.reportPublic FDA data

Application 021204

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STARLIXNATEGLINIDETABLET;ORAL60MGYesNo
002STARLIXNATEGLINIDETABLET;ORAL120MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021204-001STARLIXNATEGLINIDE60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22
N021204-002STARLIXNATEGLINIDE120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021204-001STARLIX60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021204-002STARLIX120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021204-001STARLIX60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22e64feba35796…
2022-09-29 23:25 UTC2022-09N021204-002STARLIX120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021204-001STARLIX60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021204-002STARLIX120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021204-001STARLIX60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021204-002STARLIX120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N021204-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021204-002AB1ea99ee380514…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NateglinideNATEGLINIDEGolden State Medical Supply, Inc.e920b343-f53e-7487-e053-2995a90a719a2025-04-15Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEStrides Pharma Science Limited0ccf9b07-3c21-482d-abeb-a06ceb482c7b2025-02-24Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEAmerican Health Packagingb17ead66-dc11-4e54-9ba6-00619510f27b2025-01-07Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEZydus Lifesciences Limiteda82817dd-f8c4-4172-ba86-63c2beef456a2024-12-03Name fallback
generic name: NATEGLINIDE
NATEGLINIDENATEGLINIDERising Pharma Holdings, Inc.b41f4180-96a7-411d-b827-5021e534f5562024-12-03Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEZydus Pharmaceuticals USA Inc.88698921-cd8f-4d41-96e6-ff671913c5c32023-11-07Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDECadila Pharmaceuticals Limitedc678b772-acba-4b59-a0b2-d70d842834252022-12-28Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEDr. Reddy's Laboratories Limitedf7b28951-76d2-cabd-64a1-b74aa225c6e92021-11-27Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE
NateglinideNATEGLINIDEModavar Pharmaceuticals LLCaf81465b-5f49-4eeb-8122-ef7fe5d90ddc2021-08-03Warnings, Adverse reactionsName fallback
generic name: NATEGLINIDE

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0351StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0351StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0351StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0351StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0352StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0352StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0352StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0352StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent
0078-0352StarlixnateglinideNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69166SUPPL2021-10-29
69153SUPPL2021-10-29
54246SUPPL2018-05-18
54191SUPPL2018-05-15
48133SUPPL2017-04-27
47608SUPPL2017-03-20
36342SUPPL2011-08-26
27057SUPPL2011-08-26
4631SUPPL2008-07-17
36341SUPPL2008-07-16
42020SUPPL2007-07-06
27056SUPPL2006-11-14
36340SUPPL2006-11-13
14631SUPPL2004-07-07
27055SUPPL2004-07-06
27054SUPPL2003-10-27
14630SUPPL2003-10-27
36339SUPPL2002-11-26
4630SUPPL2002-11-26
21505ORIG2002-03-18
36338ORIG2000-12-22
4629ORIG2000-12-22