Application 090252

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REPAGLINIDE	REPAGLINIDE	TABLET;ORAL	0.5MG	No	No
002	REPAGLINIDE	REPAGLINIDE	TABLET;ORAL	1MG	No	No
003	REPAGLINIDE	REPAGLINIDE	TABLET;ORAL	2MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090252-001	REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23
A090252-002	REPAGLINIDE	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22
A090252-003	REPAGLINIDE	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090252-003	REPAGLINIDE	2MG	TABLET / ORAL	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090252-001	REPAGLINIDE	0.5MG	TABLET / ORAL	2013-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090252-002	REPAGLINIDE	1MG	TABLET / ORAL	2014-01-22	`c0c555d07b60…`

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	A090252-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090252-003	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
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	6ae28683-28cc-408e-90f9-6a3dddfc668d	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	NorthStar RxLLC	7f3118ce-fcbb-4f8b-b1ba-d8cd95e5b665	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	d85abce4-16da-4231-b28a-6afca04ebf68	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Chartwell RX, LLC	cb995e92-295e-4638-a064-978211f5afe1	2025-05-02	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	9f2006d9-e0c0-4cc4-b2c9-84b7d9f77173	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	3b150917-e2fd-4366-af83-ebc1d7297ca9	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	American Health Packaging	dd1d8337-9903-4b8a-a9ea-569e4d134e74	2024-10-22	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Aurobindo Pharma Limited	68064989-47ea-4ed5-a20e-43c4ef6ec271	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Rising Pharma Holdings, Inc.	d7673e22-0dbb-4395-ad60-943d249203a1	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Macleods Pharmaceuticals Limited	7a93246c-9323-40c4-b590-a40dcb133c8c	2023-04-04	Warnings, Adverse reactions	Name fallback brand name: Repaglinide generic name: REPAGLINIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3122	Repaglinide	repaglinide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3123	Repaglinide	repaglinide	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-539	Repaglinide	repaglinide	Mylan Institutional Inc.	ANDA	Current