Application 209047

Type: ANDA
Sponsor: STRIDES 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 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
A209047-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2017-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209047-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2017-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209047-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	BX	2017-06-07	`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	A209047-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209047-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209047-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209047-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209047-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209047-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209047-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209047-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209047-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209047-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209047-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209047-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209047-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209047-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209047-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209047-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209047-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209047-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209047-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209047-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209047-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209047-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209047-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209047-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209047-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209047-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209047-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209047-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209047-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209047-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209047-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209047-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209047-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209047-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209047-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209047-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209047-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209047-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209047-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209047-001	BX	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6326d7f5-4c7c-4541-8db1-c582f1525f60	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047 ndc (product): 71335-9618
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047 ndc (product): 42543-493
Amantadine HCL	AMANTADINE HCL	Direct_Rx	f28c55c8-2754-a44d-e053-2a95a90ae798	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209047 application number: ANDA209047 ndc (product): 71205-223

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-493	Amantadine Hydrochloride	Amantadine Hydrochloride	Strides Pharma Inc.	ANDA	Current
42543-493	Amantadine Hydrochloride	Amantadine Hydrochloride	Vensun Pharmaceuticals, Inc	ANDA	Current
53002-3750	Amantadine Hydrochloride	Amantadine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3750	Amantadine Hydrochloride	Amantadine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
71205-223	Amantadine Hydrochloride	Amantadine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-223	Amantadine Hydrochloride	Amantadine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-9618	Amantadine Hydrochloride	Amantadine Hydrochloride	Bryant Ranch Prepack	ANDA	Current