Application 210403

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210403-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL			2018-02-07

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 · 43 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
2026-09-14 22:38:34	2026-08	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-02-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210403-001	AMANTADINE HYDROCHLORIDE	100MG	TABLET / ORAL		2018-02-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A210403-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210403-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210403-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210403-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210403-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210403-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210403-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210403-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210403-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210403-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210403-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210403-001	AB	1	`ea99ee380514…`

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 2 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	BAJAJ MEDICAL, LLC	38fccce5-1f1e-9350-e063-6394a90a045a	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: AMANTADINE HYDROCHLORIDE generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	e3eb34af-6e25-4a3d-a7d2-e9a789e335cc	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvPAK	461e6444-189e-62ed-6c61-1c36a04459c6	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	AvKARE	bfd129ae-8b0a-f118-b7d0-45d106290b63	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
Amantadine HCl	AMANTADINE HYDROCHLORIDE	Bionpharma Inc.	d6ca4d20-72c5-496c-9ac7-1f5cb407a742	2025-06-09	Warnings, Adverse reactions	Name fallback generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	EPIC PHARMA LLC	0f70c79a-92a4-4a38-bbdd-900adc4c2e93	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9498b7-125e-4314-baca-b62af6e5511c	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6fd54e00-a714-4442-af95-2515ab3b2ac3	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	609dc911-1e9d-4ebd-b64b-f44054e5582e	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	579e6c23-6286-4b80-88de-c86c0e5cc2b2	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	6311b46b-23cc-40c1-93c2-f7c92606386f	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: AMANTADINE HYDROCHLORIDE generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2d94073b-c064-c280-e063-6294a90af145	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	a3810649-1301-4332-85df-722b36867b1b	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2cb6e83d-e635-b150-e063-6294a90ad61d	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: amantadine hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	1f3c7c37-c488-4a88-8251-7db52dc03827	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Chartwell RX, LLC	a016ab57-d18f-4a3b-b2ab-f91fecc1eef7	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	b54064bc-b3e1-4d83-be40-fcaddd2e99d0	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Patrin Pharma, Inc.	0fcf5182-a666-4f38-879f-47f19de30dd5	2024-05-20	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	American Health Packaging	5a8f16cc-e5d5-4097-8297-10c8166c7a0e	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE
Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Strides Pharma Science Limited	20dad861-6ad1-4660-b315-8af57b294175	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Amantadine Hydrochloride generic name: AMANTADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-699	amantadine hydrochloride	Amantadine Hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-699	amantadine hydrochloride	Amantadine Hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current