Application 205055

Type: ANDA
Sponsor: ALVOGEN

Application Products#

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

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

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
A205055-001	NATEGLINIDE	NATEGLINIDE	60MG	TABLET / ORAL			2015-12-11
A205055-002	NATEGLINIDE	NATEGLINIDE	120MG	TABLET / ORAL			2015-12-11

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2015-12-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2015-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2015-12-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2015-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2015-12-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2015-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205055-001	NATEGLINIDE	60MG	TABLET / ORAL		2015-12-11	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205055-002	NATEGLINIDE	120MG	TABLET / ORAL		2015-12-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205055-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205055-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205055-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205055-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205055-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205055-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205055-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205055-002	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 · 9 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 brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Strides Pharma Science Limited	0ccf9b07-3c21-482d-abeb-a06ceb482c7b	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	American Health Packaging	b17ead66-dc11-4e54-9ba6-00619510f27b	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Zydus Lifesciences Limited	a82817dd-f8c4-4172-ba86-63c2beef456a	2024-12-03		Name fallback brand name: Nateglinide generic name: NATEGLINIDE
NATEGLINIDE	NATEGLINIDE	Rising Pharma Holdings, Inc.	b41f4180-96a7-411d-b827-5021e534f556	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: NATEGLINIDE generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Zydus Pharmaceuticals USA Inc.	88698921-cd8f-4d41-96e6-ff671913c5c3	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Cadila Pharmaceuticals Limited	c678b772-acba-4b59-a0b2-d70d84283425	2022-12-28	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Dr. Reddy's Laboratories Limited	f7b28951-76d2-cabd-64a1-b74aa225c6e9	2021-11-27	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE
Nateglinide	NATEGLINIDE	Modavar Pharmaceuticals LLC	af81465b-5f49-4eeb-8122-ef7fe5d90ddc	2021-08-03	Warnings, Adverse reactions	Name fallback brand name: Nateglinide generic name: NATEGLINIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32623	ORIG	2015-12-16