Application 205327

Type: ANDA
Sponsor: OSMOTICA

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
005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	72MG	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205327-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28
A205327-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28
A205327-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28
A205327-004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28
A205327-005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A205327-001	AB
A205327-002	AB
A205327-003	AB
A205327-004	AB
A205327-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-005	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-07-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205327-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205327-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205327-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205327-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205327-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205327-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205327-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205327-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205327-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205327-005	AB	1	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205327 application number: ANDA205327 ndc (product): 13811-706 ndc (product): 13811-707 ndc (product): 13811-709 ndc (product): 13811-708 ndc (product): 13811-710
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	22e5ddfa-7264-fbb1-e063-6394a90a6483	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205327 application number: ANDA205327
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 68025-084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49511	ORIG	2017-08-22
49194	ORIG	2017-08-02