Application 076772

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	18MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	27MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	36MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	54MG	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	TE codes	Approval date
A076772-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22
A076772-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22
A076772-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076772-001	AB
A076772-002	AB
A076772-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076772-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-03-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076772-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076772-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076772-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076772-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076772-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076772-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076772-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076772-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076772-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076772-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076772-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076772-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076772-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076772-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076772-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076772-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076772-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076772-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076772-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076772-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076772-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076772-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076772-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076772-001	AB	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Actavis Pharma, Inc.	85ef422d-af27-4126-9841-6892af1871d6	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076772 application number: ANDA076772 ndc (product): 62037-734 ndc (product): 62037-726 ndc (product): 62037-725

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62037-725	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-725	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-725	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-726	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-726	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-726	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-734	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-734	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
62037-734	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Actavis Pharma, Inc.	ANDA	Current