Application 090453

Type: ANDA
Sponsor: EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	TABLET;ORAL	25MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A090453-001	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20
A090453-002	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20
A090453-003	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090453-002	MOLINDONE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090453-003	MOLINDONE HYDROCHLORIDE	25MG	TABLET / ORAL	RS	2015-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090453-001	MOLINDONE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-03-20	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Molindone Hydrochloride	MOLINDONE HYDROCHLORIDE	EPIC PHARMA, LLC	1275e92f-9573-4d0c-8e77-1c9ac47696d2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090453 application number: ANDA090453 ndc (product): 42806-336 ndc (product): 42806-337 ndc (product): 42806-338

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
42806-336	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-336	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-337	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-337	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-338	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-338	Molindone Hydrochloride	Molindone Hydrochloride	EPIC PHARMA, LLC	ANDA	Current