Application 040306

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METADATE ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	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
A040306-001	METADATE ER	METHYLPHENIDATE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL			1999-10-20

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040306-001	METADATE ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040306-001	METADATE ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040306-001	METADATE ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040306-001	METADATE ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040306-001	METADATE ER	10MG	TABLET, EXTENDED RELEASE / ORAL	1999-10-20	`f41ea6bd6efb…`

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 4 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Eywa Pharma Inc	298fb86d-7d94-49e1-b743-3e7801122422	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylin	METHYLPHENIDATE HYDROCHLORIDE	SHIONOGI INC.	9e3c22d9-71d9-46a7-b315-8021c94c4bec	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	981a2ad8-33f7-4678-9162-9df9685bd4a6	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	91833146-fa95-471a-8b8d-6d36a2db5c9a	2023-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals Inc.	bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0	2023-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	59de488c-c3f8-415d-9e9f-9102c090aac8	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	5fa3da25-13aa-4ee3-acf5-cd505f4688d0	2021-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals Inc	94dc74d4-b4ef-45bc-b502-54ec692e9bd5	2021-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	b9af3104-172d-4975-9301-b9fe7db9ef12	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	b07150db-fd99-4400-bb83-b3a7544a917a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	45ebb59c-9603-4df6-b1be-3295ba2db1e7	2021-01-29	Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44190	ORIG	2007-05-18
42612	ORIG	2003-12-23
17767	ORIG	2003-12-23
29921	ORIG	1999-10-20