Application 074170

Type: ANDA
Sponsor: HI TECH PHARMA

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
A074170-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074170-001	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	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074170-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1994-10-28	`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	A074170-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074170-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074170-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074170-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074170-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074170-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074170-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074170-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074170-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074170-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074170-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074170-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074170-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074170-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074170-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074170-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074170-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074170-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074170-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074170-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074170-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074170-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074170-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074170-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074170-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074170-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074170-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074170-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074170-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074170-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074170-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074170-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074170-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074170-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074170-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074170-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074170-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074170-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074170-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074170-001	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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	AvKARE	547904f3-84a3-1ccb-e063-6294a90a6fb6	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	A-S Medication Solutions	da693bb0-0cc8-485d-89a7-c8cf28d440f3	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6326d7f5-4c7c-4541-8db1-c582f1525f60	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Cardinal Health 107, LLC	5989098d-2855-4b5f-9a06-64a83656c078	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: AMANTADINE HYDROCHLORIDE generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	Zhejiang Jutai Pharmaceutical Co., Ltd.	9c5e0c61-372b-4d1b-8882-e13f6af8fed0	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: AMANTADINE HYDROCHLORIDE generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	e4d8f36f-d668-4728-8dca-b1c22bd9aedb	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Major Pharmaceuticals	b2f7da34-ad78-4db3-9af1-bdd341e09f16	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	3c448cb3-7996-4a83-a9ad-23a00a431fbe	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Inc.	9a99bb98-82a4-4b9e-9216-554dade72a3c	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	52aa093c-82cc-4d81-b072-86a2b8adc9c5	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	63d9d4aa-5f92-45b0-98d0-d6ec38b727cb	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	96aefbca-fe71-42ef-8079-d0d9e7370ccb	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	a10bf8b5-bf70-4090-b4b2-a0be252b9fe4	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Marlex Pharmaceuticals Inc	25af52ee-9b29-4c07-a383-62d4537b63e0	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3dd7f2a6-5a91-81a2-e063-6294a90a33db	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	be411327-5ac7-46df-b5e4-32a11b419b15	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: AMANTADINE HYDROCHLORIDE generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	8e578f11-6112-4a1f-8de4-a76870bb62c7	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Advagen Pharma Limited	c3b9e7f0-be6d-4f37-9277-54bb0ba8b158	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5232b933-1df9-43b4-8ac2-61bfa4855e68	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-807	Amantadine Hydrochloride	Amantadine Hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-807	Amantadine Hydrochloride	Amantadine Hydrochloride	Akorn	ANDA	Current
50383-807	Amantadine Hydrochloride	Amantadine Hydrochloride	Akorn	ANDA	Current
50383-807	Amantadine Hydrochloride	Amantadine Hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-807	Amantadine Hydrochloride	Amantadine Hydrochloride	Akorn	ANDA	Current
68788-7088	Amantadine Hydrochloride	Amantadine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current