Application 071293

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	CAPSULE;ORAL	100MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A071293-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071293-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	RS	1987-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071293-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		1987-02-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071293-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071293-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071293-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071293-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071293-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071293-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071293-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071293-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071293-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071293-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071293-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071293-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071293-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071293-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071293-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071293-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071293-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071293-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071293-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071293-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071293-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071293-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071293-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071293-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071293-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071293-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071293-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071293-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071293-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071293-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071293-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071293-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071293-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071293-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071293-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071293-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071293-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071293-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071293-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071293-001	AB	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	A-S Medication Solutions	da693bb0-0cc8-485d-89a7-c8cf28d440f3	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071293 application number: ANDA071293 ndc (product): 50090-0020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-0326	Amantadine Hydrochloride	Amantadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-2048	Amantadine Hydrochloride	Amantadine Hydrochloride	Sandoz Inc	ANDA	Current
0781-2320	Amantadine Hydrochloride	Amantadine Hydrochloride	Sandoz Inc.	ANDA	Current
0832-2012	Amantadine Hydrochloride	Amantadine Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
33261-773	Amantadine Hydrochloride	Amantadine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43353-947	Amantadine Hydrochloride	Amantadine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0020	Amantadine Hydrochloride	Amantadine Hydrochloride	A-S Medication Solutions	ANDA	Current
51079-247	Amantadine Hydrochloride	Amantadine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
68084-611	Amantadine Hydrochloride	Amantadine Hydrochloride	American Health Packaging	ANDA	Current
68151-2991	Amantadine Hydrochloride	Amantadine Hydrochloride	Carilion Materials Management	ANDA	Current