Application 209171

Type: ANDA
Sponsor: HERITAGE PHARMA

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
A209171-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209171-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209171-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-12	`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	A209171-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209171-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209171-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209171-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209171-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209171-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209171-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209171-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209171-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209171-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209171-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209171-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209171-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209171-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209171-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209171-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209171-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209171-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209171-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209171-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209171-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209171-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209171-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209171-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209171-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209171-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209171-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209171-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209171-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209171-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209171-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209171-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209171-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209171-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209171-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209171-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209171-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209171-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209171-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209171-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Major Pharmaceuticals	b2f7da34-ad78-4db3-9af1-bdd341e09f16	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171 ndc (product): 0904-7042
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	96aefbca-fe71-42ef-8079-d0d9e7370ccb	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	a10bf8b5-bf70-4090-b4b2-a0be252b9fe4	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	e3eb34af-6e25-4a3d-a7d2-e9a789e335cc	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9498b7-125e-4314-baca-b62af6e5511c	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171 ndc (product): 23155-362
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	1f3c7c37-c488-4a88-8251-7db52dc03827	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	a016ab57-d18f-4a3b-b2ab-f91fecc1eef7	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	b54064bc-b3e1-4d83-be40-fcaddd2e99d0	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209171 application number: ANDA209171 ndc (product): 0615-8263

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8263	Amantadine Hydrochloride	Amantadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8263	Amantadine Hydrochloride	Amantadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-7042	Amantadine Hydrochloride	Amantadine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7042	Amantadine Hydrochloride	Amantadine Hydrochloride	Major Pharmaceuticals	ANDA	Current
23155-362	Amantadine Hydrochloride	Amantadine Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-362	Amantadine Hydrochloride	Amantadine Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-362	Amantadine Hydrochloride	Amantadine Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-362	Amantadine Hydrochloride	Amantadine Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current