Application 078720

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	CAPSULE;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078720-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078720-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2008-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078720-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	2008-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078720-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078720-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078720-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078720-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078720-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078720-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078720-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078720-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078720-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078720-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078720-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078720-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078720-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078720-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078720-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078720-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078720-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078720-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078720-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078720-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078720-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078720-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078720-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078720-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078720-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078720-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078720-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078720-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078720-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078720-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078720-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078720-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078720-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078720-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078720-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078720-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078720-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078720-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078720-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078720-001	AB	1	`cb3db0bc1861…`

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
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	461e6444-189e-62ed-6c61-1c36a04459c6	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720 ndc (product): 50268-069
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE	bfd129ae-8b0a-f118-b7d0-45d106290b63	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720 ndc (product): 42291-125
Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bionpharma Inc.	d6ca4d20-72c5-496c-9ac7-1f5cb407a742	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078720 application number: ANDA078720 ndc (product): 69452-142

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1704	Amantadine Hydrochloride	Amantadine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1704	Amantadine Hydrochloride	Amantadine Hydrochloride	Lannett Company, Inc.	ANDA	Current
10888-5006	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Banner Pharmacaps Inc	ANDA	Current
21695-564	Amantadine HCl	Amantadine hydrochloride	Rebel Distributors Corp.	ANDA	Current
42291-125	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE, Inc.	ANDA	Current
42291-125	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE, Inc.	ANDA	Current
42291-125	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE	ANDA	Current
50268-069	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	ANDA	Current
50268-069	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	ANDA	Current
50268-069	Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	ANDA	Current
53808-0933	Amantadine HCl	AMANTADINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
63629-2681	Amantadine HCl	Amantadine hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-9530	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
69387-100	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Banner Life Sciences LLC.	ANDA	Current
69452-142	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bionpharma Inc.	ANDA	Current
71335-0279	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0279	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0279	Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current