Application 077107

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29
A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29
A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29

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 · 129 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	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077107-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077107-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2007-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077107-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-01-29	`301d65b070ca…`

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a03d8819-a315-4337-ac50-530af98082b0	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	424da264-7448-4364-939f-d3ebbee1a6d7	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d3318fec-a1bc-4e3c-86a9-3f00ec296869	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c423a632-e8e0-44a7-a8a8-f66cec81aa64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	1f2aa66a-51dc-459c-a765-5364bccd310f	2024-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	830df993-db01-40df-beef-90af6b86f561	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f930af78-760b-42c7-af30-ffcc64c4d35d	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a0133bf5-3cb3-4405-a007-43fbcf957333	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	32b3c189-f0f8-4f3e-87da-ce56f583fc42	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	2016f5c2-95d2-4655-af65-c588c2bf5e6d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	17950616-ab96-4d7e-be48-f36cae547de0	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f65759db-5294-4e82-bb3c-3ea368edaca7	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ea04c0e3-0be3-4607-bd59-29f611e6681b	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	e304388e-86a6-4335-abae-0ce79c7c99c6	2024-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	a61932ef-c2b6-4363-a21d-1f0358f317b6	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	f88da72d-c22f-413b-9dce-60871299b06a	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	987b4983-1edc-40f1-adc9-724747080969	2024-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	77659abe-74be-4092-90fe-cc475726d4ec	2021-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEXMETHYLPHENIDATE HYDROCHLORIDE generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5275	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5275	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5275	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5276	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5276	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5276	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5277	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5277	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5277	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0143-3367	Flurazepam	Flurazepam Hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31197	ORIG	2007-02-12