Application 020741

Type: NDA
Sponsor: GEMINI LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRANDIN	REPAGLINIDE	TABLET;ORAL	0.5MG	Yes	No
002	PRANDIN	REPAGLINIDE	TABLET;ORAL	1MG	Yes	No
003	PRANDIN	REPAGLINIDE	TABLET;ORAL	2MG	Yes	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	RLD / RS	Approval date
N020741-001	PRANDIN	REPAGLINIDE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22
N020741-002	PRANDIN	REPAGLINIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22
N020741-003	PRANDIN	REPAGLINIDE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N020741-003	PRANDIN	2MG	TABLET / ORAL	RLD	1997-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020741-001	PRANDIN	0.5MG	TABLET / ORAL	RLD	1997-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020741-002	PRANDIN	1MG	TABLET / ORAL	RLD	1997-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020741-003	PRANDIN	2MG	TABLET / ORAL	RLD	1997-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020741-001	PRANDIN	0.5MG	TABLET / ORAL	RLD	1997-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020741-002	PRANDIN	1MG	TABLET / ORAL	RLD	1997-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020741-003	PRANDIN	2MG	TABLET / ORAL	RLD	1997-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020741-001	PRANDIN	0.5MG	TABLET / ORAL	RLD	1997-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020741-002	PRANDIN	1MG	TABLET / ORAL	RLD	1997-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020741-003	PRANDIN	2MG	TABLET / ORAL	RLD	1997-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020741-001	PRANDIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020741-002	PRANDIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020741-003	PRANDIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-12-22	`3a93d1ddd44b…`

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 generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	NorthStar RxLLC	7f3118ce-fcbb-4f8b-b1ba-d8cd95e5b665	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	d85abce4-16da-4231-b28a-6afca04ebf68	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Chartwell RX, LLC	cb995e92-295e-4638-a064-978211f5afe1	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	9f2006d9-e0c0-4cc4-b2c9-84b7d9f77173	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	3b150917-e2fd-4366-af83-ebc1d7297ca9	2025-01-16	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	American Health Packaging	dd1d8337-9903-4b8a-a9ea-569e4d134e74	2024-10-22	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Aurobindo Pharma Limited	68064989-47ea-4ed5-a20e-43c4ef6ec271	2024-05-14	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Rising Pharma Holdings, Inc.	d7673e22-0dbb-4395-ad60-943d249203a1	2024-05-14	Warnings, Adverse reactions	Name fallback generic name: REPAGLINIDE
Repaglinide	REPAGLINIDE	Macleods Pharmaceuticals Limited	7a93246c-9323-40c4-b590-a40dcb133c8c	2023-04-04	Warnings, Adverse reactions	Name fallback 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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-0081	Prandin	repaglinide	Novo Nordisk	NDA	Current
0169-0082	Prandin	repaglinide	Novo Nordisk	NDA	Current
0169-0084	Prandin	repaglinide	Novo Nordisk	NDA	Current
68151-3565	Prandin	repaglinide	Carilion Materials Management	NDA	Current
68151-3566	Prandin	repaglinide	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57515	SUPPL	2019-02-13
57327	SUPPL	2019-01-23
57326	ORIG	2019-01-23
47153	SUPPL	2017-02-09
47152	SUPPL	2017-02-09
47145	SUPPL	2017-02-09
47144	SUPPL	2017-02-09
13325	SUPPL	2012-03-06
3244	SUPPL	2012-03-05
3243	SUPPL	2010-08-03
13324	SUPPL	2010-07-31
35253	SUPPL	2009-06-22
3242	SUPPL	2009-06-16
13323	SUPPL	2008-07-15
3241	SUPPL	2008-07-15
41637	SUPPL	2007-07-06
41636	SUPPL	2007-07-06
41635	SUPPL	2007-07-06
20893	SUPPL	2007-07-06
20892	SUPPL	2007-07-06
3240	SUPPL	2006-06-28
13322	SUPPL	2005-02-11
3239	SUPPL	2005-02-11
3238	SUPPL	2003-10-17
25668	SUPPL	2003-08-29
13321	SUPPL	2003-08-29
25667	SUPPL	2002-10-21
13320	SUPPL	2002-10-21
13319	SUPPL	2002-01-18
3237	SUPPL	2002-01-18