Application 208278

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A208278-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB		2016-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208278-001	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	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208278-001	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2016-05-31	`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	A208278-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208278-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208278-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208278-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208278-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208278-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208278-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208278-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208278-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208278-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208278-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208278-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208278-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208278-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208278-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208278-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208278-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208278-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208278-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208278-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208278-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208278-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208278-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208278-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208278-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208278-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208278-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208278-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208278-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208278-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208278-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208278-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208278-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208278-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208278-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208278-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208278-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208278-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208278-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208278-001	AB	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 · 6 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	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Bryant Ranch Prepack	8e578f11-6112-4a1f-8de4-a76870bb62c7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278 ndc (product): 71335-0469
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	609dc911-1e9d-4ebd-b64b-f44054e5582e	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278 ndc (product): 68382-512
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	579e6c23-6286-4b80-88de-c86c0e5cc2b2	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278 ndc (product): 65841-835
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Coupler LLC	2cb6e83d-e635-b150-e063-6294a90ad61d	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278
amantadine hydrochloride	AMANTADINE HYDROCHLORIDE	Proficient Rx LP	743d1b73-f47e-4bbf-bb52-45b1e7f17308	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208278 application number: ANDA208278 ndc (product): 71205-702

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6630	amantadine hydrochloride	amantadine hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6630	amantadine hydrochloride	amantadine hydrochloride	Major Pharmaceuticals	ANDA	Current
65841-835	amantadine hydrochloride	amantadine hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-835	amantadine hydrochloride	amantadine hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-835	amantadine hydrochloride	amantadine hydrochloride	Cadila Healthcare Limited	ANDA	Current
68382-512	amantadine hydrochloride	amantadine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-512	amantadine hydrochloride	amantadine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-512	amantadine hydrochloride	amantadine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-6975	amantadine hydrochloride	amantadine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6975	amantadine hydrochloride	amantadine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6975	amantadine hydrochloride	amantadine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6975	amantadine hydrochloride	amantadine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-702	amantadine hydrochloride	amantadine hydrochloride	Proficient Rx LP	ANDA	Current
71335-0469	amantadine hydrochloride	amantadine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0469	amantadine hydrochloride	amantadine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0469	amantadine hydrochloride	amantadine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0469	amantadine hydrochloride	amantadine hydrochloride	Bryant Ranch Prepack	ANDA	Current