Application 073458

Type: ANDA
Sponsor: PLD ACQUISITIONS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	TABLET;ORAL	1.34MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A073458-001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL			1993-10-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073458-001	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	1993-10-31	`cb3db0bc1861…`

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
CLEMSZA	CLEMASTINE FUMARATE	IPG Pharmaceuticals, Inc.	9a35ed77-e35c-4c54-ad7f-1b92e450fa20	2025-07-30	Warnings, Adverse reactions	Name fallback generic name: CLEMASTINE FUMARATE
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	cf8a3449-8bb3-4d5c-8d0d-557590e49ee5	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Clemastine Fumarate generic name: CLEMASTINE FUMARATE
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	5c99e7af-86a5-4c17-82d5-2d4119e4fe72	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: Clemastine Fumarate generic name: CLEMASTINE FUMARATE
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	Chartwell RX, LLC	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	2023-07-07	Warnings, Adverse reactions	Name fallback brand name: CLEMASTINE FUMARATE generic name: CLEMASTINE FUMARATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68151-2456	Clemastine Fumarate	Clemastine Fumarate	Carilion Materials Management	ANDA	Current