Application 075060

Type: ANDA
Sponsor: WOCKHARDT BIO AG

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
A075060-001	AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075060-001	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	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA		1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	AA	RS	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075060-001	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL			1998-12-24	`e64feba35796…`

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	A075060-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075060-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075060-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075060-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075060-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075060-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075060-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075060-001	AA	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075060-001	AA	1	`d8e5a09893c0…`
2019-12-13 00:20 UTC	2019-12	A075060-001	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A075060-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075060-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075060-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075060-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075060-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075060-001	AA	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amantadine	AMANTADINE	AvPAK	48c949e3-86e0-c639-e063-6294a90acdba	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075060 application number: ANDA075060
Amantadine	AMANTADINE	Xttrium Laboratories, Inc	25dd8a3c-6b11-2ea1-e063-6294a90a50cf	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075060 application number: ANDA075060

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0093	Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Atlantic Biologicals Corps	ANDA	Current
17856-0093	Amantadine Hydrochloride	AMANTADINE HYDROCHLORIDE	Atlantic Biologicals Corps	ANDA	Current
60432-093	Amantadine Hydrochloride	Amantadine Hydrochloride	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60687-239	Amantadine Hydrochloride	Amantadine Hydrochloride	American Health Packaging	ANDA	Current
60687-239	Amantadine Hydrochloride	Amantadine Hydrochloride	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8512	ORIG	1998-12-24