Application 212044

Type: ANDA
Sponsor: RUBICON

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
A212044-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2020-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212044-001	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.

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	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212044-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2020-05-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212044-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212044-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212044-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212044-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212044-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212044-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212044-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212044-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212044-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212044-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212044-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212044-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212044-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212044-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212044-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212044-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212044-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212044-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212044-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212044-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212044-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212044-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212044-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212044-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212044-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212044-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212044-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212044-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212044-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212044-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212044-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212044-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212044-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212044-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212044-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212044-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212044-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212044-001	AB	1	`a50c72e98297…`

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	56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212044 application number: ANDA212044
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3dd7f2a6-5a91-81a2-e063-6294a90a33db	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212044 application number: ANDA212044
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Advagen Pharma Limited	c3b9e7f0-be6d-4f37-9277-54bb0ba8b158	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212044 application number: ANDA212044 ndc (product): 72888-033
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	a3810649-1301-4332-85df-722b36867b1b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212044 application number: ANDA212044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-033	Amantadine Hydrochloride	Amantadine Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-033	Amantadine Hydrochloride	Amantadine Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-033	Amantadine Hydrochloride	Amantadine Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-033	Amantadine Hydrochloride	Amantadine Hydrochloride	Advagen Pharma Limited	ANDA	Current