Application 203965

Type: ANDA
Sponsor: ORIENT PHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIGLITOL	MIGLITOL	TABLET;ORAL	25MG	No	No
002	MIGLITOL	MIGLITOL	TABLET;ORAL	50MG	No	No
003	MIGLITOL	MIGLITOL	TABLET;ORAL	100MG	No	No

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

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
A203965-001	MIGLITOL	MIGLITOL	25MG	TABLET / ORAL	RS	2015-02-24
A203965-002	MIGLITOL	MIGLITOL	50MG	TABLET / ORAL		2015-02-24
A203965-003	MIGLITOL	MIGLITOL	100MG	TABLET / ORAL		2015-02-24

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 · 129 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
2026-09-14 22:38:34	2026-08	A203965-001	MIGLITOL	25MG	TABLET / ORAL		RS	2015-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203965-002	MIGLITOL	50MG	TABLET / ORAL			2015-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203965-003	MIGLITOL	100MG	TABLET / ORAL			2015-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203965-001	MIGLITOL	25MG	TABLET / ORAL		RS	2015-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203965-002	MIGLITOL	50MG	TABLET / ORAL			2015-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203965-003	MIGLITOL	100MG	TABLET / ORAL			2015-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203965-001	MIGLITOL	25MG	TABLET / ORAL		RS	2015-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203965-002	MIGLITOL	50MG	TABLET / ORAL			2015-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203965-003	MIGLITOL	100MG	TABLET / ORAL			2015-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203965-001	MIGLITOL	25MG	TABLET / ORAL		RS	2015-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203965-002	MIGLITOL	50MG	TABLET / ORAL			2015-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203965-003	MIGLITOL	100MG	TABLET / ORAL			2015-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203965-002	MIGLITOL	50MG	TABLET / ORAL	AB		2015-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203965-003	MIGLITOL	100MG	TABLET / ORAL	AB		2015-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203965-001	MIGLITOL	25MG	TABLET / ORAL	AB		2015-02-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A203965-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203965-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203965-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203965-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203965-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203965-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203965-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203965-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203965-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203965-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203965-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203965-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203965-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203965-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203965-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203965-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203965-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203965-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203965-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203965-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203965-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203965-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203965-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203965-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203965-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203965-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203965-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203965-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203965-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203965-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203965-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203965-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203965-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203965-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203965-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203965-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203965-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203965-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203965-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203965-002	AB	1	`1c564ffb4f44…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miglitol	MIGLITOL	Proficient Rx LP	f16ecb50-e54e-43e1-8789-eaf5bc94f332	2022-04-01	Adverse reactions	Exact identifier application applno (ANDA): 203965 application number: ANDA203965 ndc (product): 71205-936 ndc (product): 71205-935 ndc (product): 71205-937
Miglitol	MIGLITOL	Westminster Pharmaceuticals, LLC	b8da2015-d254-2425-e053-2995a90acf0e	2021-12-07	Adverse reactions	Exact identifier application applno (ANDA): 203965 application number: ANDA203965 ndc (product): 69367-305 ndc (product): 69367-304 ndc (product): 69367-303

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-684	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
57664-684	Miglitol	Miglitol	Sun Pharmaceutical Industries Inc.	ANDA	Current
57664-684	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
57664-685	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
57664-685	Miglitol	Miglitol	Sun Pharmaceutical Industries Inc.	ANDA	Current
57664-685	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
57664-686	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
57664-686	Miglitol	Miglitol	Sun Pharmaceutical Industries Inc.	ANDA	Current
57664-686	Miglitol	Miglitol	Sun Pharmaceutical Industries Ltd.	ANDA	Current
69367-303	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-303	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-304	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-304	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-305	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-305	Miglitol	Miglitol	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-935	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
71205-935	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
71205-936	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
71205-936	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
71205-937	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
71205-937	Miglitol	Miglitol	Proficient Rx LP	ANDA	Current
76333-125	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current
76333-125	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current
76333-126	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current
76333-126	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current
76333-127	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current
76333-127	Miglitol	Miglitol	Orient Pharma Co., Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10260	ORIG	2015-03-03