Application 074509

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	SYRUP;ORAL	50MG/5ML	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
A074509-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074509-001	AA

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	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074509-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1995-07-17	`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	A074509-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074509-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074509-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074509-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074509-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074509-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074509-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074509-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074509-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074509-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074509-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074509-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074509-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074509-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074509-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074509-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074509-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074509-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074509-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074509-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074509-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074509-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074509-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074509-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074509-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074509-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074509-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074509-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074509-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074509-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074509-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074509-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074509-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074509-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074509-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074509-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074509-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074509-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074509-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074509-001	AA	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	Cardinal Health 107, LLC	5989098d-2855-4b5f-9a06-64a83656c078	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509 ndc (product): 55154-9444
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	be411327-5ac7-46df-b5e4-32a11b419b15	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509 ndc (product): 0121-0646
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	6311b46b-23cc-40c1-93c2-f7c92606386f	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509 ndc (product): 17856-0646
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	American Health Packaging	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074509 application number: ANDA074509

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50436-0646	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Unit Dose Services	ANDA	Current
55154-9444	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health, Inc.	ANDA	Current
55154-9444	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-9444	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-9444	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
68151-0910	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Carilion Materials Management	ANDA	Current