Application 091053

Type: ANDA
Sponsor: MYLAN

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 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
A091053-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	2011-01-06
A091053-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	2011-01-06
A091053-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	2011-01-06

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	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091053-003	ACARBOSE	100MG	TABLET / ORAL	2011-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091053-001	ACARBOSE	25MG	TABLET / ORAL	2011-01-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091053-002	ACARBOSE	50MG	TABLET / ORAL	2011-01-06	`c0c555d07b60…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acarbose	ACARBOSE	Bryant Ranch Prepack	1ba7a072-03b0-41f2-be7a-101145bdef3a	2026-08-11	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	Bryant Ranch Prepack	067c0adc-7322-489d-9baa-1d061b37be36	2026-07-16	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	Strides Pharma Science Limited	656769ee-e292-4950-83df-a38e6b1a9d6e	2026-07-15	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	PD-Rx Pharmaceuticals, Inc.	722ce9eb-8f7b-4651-a287-d53dd7ab3707	2026-06-24	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	29939129-7d09-4c22-bf3e-491a8a97f4c4	2026-06-18	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	Chartwell RX, LLC	d1b627e1-d78d-47dd-93f5-2bf4998466ba	2025-12-09	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE
Acarbose	ACARBOSE	Hikma Pharmaceuticals USA Inc.	352dd336-d3f9-4ac5-a000-91d3aef7aca3	2024-07-19	Adverse reactions	Name fallback brand name: Acarbose generic name: ACARBOSE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.