Application 021204

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STARLIX	NATEGLINIDE	TABLET;ORAL	60MG	Yes	No
002	STARLIX	NATEGLINIDE	TABLET;ORAL	120MG	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021204-001	STARLIX	NATEGLINIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-12-22
N021204-002	STARLIX	NATEGLINIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-12-22

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N021204-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021204-002	AB	1	`ea99ee380514…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nateglinide	NATEGLINIDE	Golden State Medical Supply, Inc.	e920b343-f53e-7487-e053-2995a90a719a	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Strides Pharma Science Limited	0ccf9b07-3c21-482d-abeb-a06ceb482c7b	2025-02-24	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	American Health Packaging	b17ead66-dc11-4e54-9ba6-00619510f27b	2025-01-07	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Zydus Lifesciences Limited	a82817dd-f8c4-4172-ba86-63c2beef456a	2024-12-03		Name fallback generic name: NATEGLINIDE
NATEGLINIDE	NATEGLINIDE	Rising Pharma Holdings, Inc.	b41f4180-96a7-411d-b827-5021e534f556	2024-12-03	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Zydus Pharmaceuticals USA Inc.	88698921-cd8f-4d41-96e6-ff671913c5c3	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Cadila Pharmaceuticals Limited	c678b772-acba-4b59-a0b2-d70d84283425	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Dr. Reddy's Laboratories Limited	f7b28951-76d2-cabd-64a1-b74aa225c6e9	2021-11-27	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Modavar Pharmaceuticals LLC	af81465b-5f49-4eeb-8122-ef7fe5d90ddc	2021-08-03	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE
NATEGLINIDE	NATEGLINIDE	Nivagen Pharmaceuticals, Inc.	21b211b5-cc92-490f-9903-42fff6a946cd	2021-01-15	Warnings, Adverse reactions	Name fallback generic name: NATEGLINIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0351	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0351	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0351	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0351	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0352	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0352	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0352	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0352	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0352	Starlix	nateglinide	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69166	SUPPL	2021-10-29
69153	SUPPL	2021-10-29
54246	SUPPL	2018-05-18
54191	SUPPL	2018-05-15
48133	SUPPL	2017-04-27
47608	SUPPL	2017-03-20
36342	SUPPL	2011-08-26
27057	SUPPL	2011-08-26
4631	SUPPL	2008-07-17
36341	SUPPL	2008-07-16
42020	SUPPL	2007-07-06
27056	SUPPL	2006-11-14
36340	SUPPL	2006-11-13
14631	SUPPL	2004-07-07
27055	SUPPL	2004-07-06
27054	SUPPL	2003-10-27
14630	SUPPL	2003-10-27
36339	SUPPL	2002-11-26
4630	SUPPL	2002-11-26
21505	ORIG	2002-03-18
36338	ORIG	2000-12-22
4629	ORIG	2000-12-22