Application 078470

Type: ANDA
Sponsor: HIKMA

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
A078470-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07
A078470-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07
A078470-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078470-001	AB
A078470-002	AB
A078470-003	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	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`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	A078470-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078470-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078470-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078470-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acarbose	ACARBOSE	PD-Rx Pharmaceuticals, Inc.	722ce9eb-8f7b-4651-a287-d53dd7ab3707	2026-06-24	Adverse reactions	Exact identifier application applno (ANDA): 078470 application number: ANDA078470 ndc (product): 72789-132 ndc (product): 72789-133 ndc (product): 72789-131
Acarbose	ACARBOSE	Hikma Pharmaceuticals USA Inc.	352dd336-d3f9-4ac5-a000-91d3aef7aca3	2024-07-19	Adverse reactions	Exact identifier application applno (ANDA): 078470 application number: ANDA078470 ndc (product): 0054-0142 ndc (product): 0054-0141 ndc (product): 0054-0140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0140	Acarbose	Acarbose	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0140	Acarbose	Acarbose	West-Ward Pharmaceuticals Inc.	ANDA	Current
0054-0141	Acarbose	Acarbose	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0141	Acarbose	Acarbose	West-Ward Pharmaceuticals Inc.	ANDA	Current
0054-0142	Acarbose	Acarbose	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0142	Acarbose	Acarbose	West-Ward Pharmaceuticals Inc.	ANDA	Current
55289-171	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-131	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-131	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-131	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-131	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-131	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-132	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-132	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-132	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-132	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-132	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-133	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-133	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-133	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-133	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-133	Acarbose	Acarbose	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9158	ORIG	2008-05-09