Application 203820

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
A203820-001	REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22
A203820-002	REPAGLINIDE	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22
A203820-003	REPAGLINIDE	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203820-001	AB
A203820-002	AB
A203820-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203820-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203820-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203820-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203820-001	AB	1	`8072bd15b7f6…`

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 · 5 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	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	3b150917-e2fd-4366-af83-ebc1d7297ca9	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	American Health Packaging	dd1d8337-9903-4b8a-a9ea-569e4d134e74	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820 ndc (product): 60687-560
Repaglinide	REPAGLINIDE	Aurobindo Pharma Limited	68064989-47ea-4ed5-a20e-43c4ef6ec271	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820 ndc (product): 65862-670 ndc (product): 65862-671 ndc (product): 65862-672
Repaglinide	REPAGLINIDE	Rising Pharma Holdings, Inc.	d7673e22-0dbb-4395-ad60-943d249203a1	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820 ndc (product): 57237-159 ndc (product): 57237-158 ndc (product): 57237-157

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-157	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-157	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-157	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-157	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-158	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-158	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-158	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-158	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-159	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-159	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-159	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
57237-159	Repaglinide	Repaglinide	Rising Health, LLC	ANDA	Current
60687-560	Repaglinide	Repaglinide	American Health Packaging	ANDA	Current
60687-560	Repaglinide	Repaglinide	American Health Packaging	ANDA	Current
63629-8363	Repaglinide	Repaglinide	Bryant Ranch Prepack	ANDA	Current
63629-8363	Repaglinide	Repaglinide	Bryant Ranch Prepack	ANDA	Current
65862-670	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-670	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-670	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-670	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-671	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-671	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-671	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-671	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-672	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-672	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-672	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current
65862-672	Repaglinide	Repaglinide	Aurobindo Pharma Limited	ANDA	Current