Application 202271

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

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

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	Approval date
A202271-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07
A202271-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07
A202271-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202271-001	AB
A202271-002	AB
A202271-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A202271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202271-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acarbose	ACARBOSE	Bryant Ranch Prepack	067c0adc-7322-489d-9baa-1d061b37be36	2026-07-16	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271
Acarbose	ACARBOSE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	29939129-7d09-4c22-bf3e-491a8a97f4c4	2026-06-18	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271 ndc (product): 23155-148 ndc (product): 23155-149 ndc (product): 23155-147
Acarbose	ACARBOSE	Chartwell RX, LLC	d1b627e1-d78d-47dd-93f5-2bf4998466ba	2025-12-09	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-147	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-147	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-147	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-147	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-147	Acarbose	Acarbose	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-148	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-148	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-148	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-148	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-148	Acarbose	Acarbose	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-149	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-149	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-149	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-149	Acarbose	Acarbose	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-149	Acarbose	Acarbose	Heritage Pharmaceuticals Inc.	ANDA	Current