Application 213813

Type: ANDA
Sponsor: GRANULES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A213813-001	AB
A213813-002	AB
A213813-003	AB
A213813-004	AB
A213813-005	AB
A213813-006	AB
A213813-007	AB
A213813-008	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 8 · 296 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
2026-02-19 14:30 UTC	2026-02	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 296 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	A213813-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213813-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-008	AB	1	`b8a1b40f171c…`

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
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213813 application number: ANDA213813 ndc (product): 70010-010 ndc (product): 70010-004 ndc (product): 70010-005 ndc (product): 70010-011 ndc (product): 70010-009 ndc (product): 70010-007 ndc (product): 70010-008 ndc (product): 70010-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-009	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-009	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-009	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-009	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-010	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-010	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-010	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-010	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-011	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-011	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-011	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-011	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current