Application 078441

Type: ANDA
Sponsor: IMPAX LABS

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	TE codes	Approval date
A078441-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14
A078441-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14
A078441-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078441-001	AB
A078441-002	AB
A078441-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078441-002	ACARBOSE	50MG	TABLET / ORAL	AB	2009-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078441-003	ACARBOSE	100MG	TABLET / ORAL	AB	2009-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078441-001	ACARBOSE	25MG	TABLET / ORAL	AB	2009-05-14	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078441-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078441-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078441-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078441-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078441-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078441-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078441-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078441-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078441-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078441-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078441-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078441-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078441-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078441-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078441-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078441-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078441-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078441-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078441-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078441-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078441-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078441-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078441-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078441-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078441-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078441-001	AB	1	`79d66fd596c7…`

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.