Application 202731

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL25MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo
003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo
004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL35MGNoNo
005DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05
A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19
A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19
A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A202731-001AB
A202731-002AB
A202731-003AB
A202731-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-001DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-002DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2013-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-003DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2014-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-004DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2017-07-05d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202731-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202731-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202731-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202731-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202731-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202731-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202731-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202731-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202731-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202731-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202731-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202731-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202731-004AB1d8e5a09893c0…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.dd659d39-41f5-4612-8f17-bad602b4784d2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202731
application number: ANDA202731
ndc (product): 0093-5045
ndc (product): 0093-5562
ndc (product): 0093-5554
ndc (product): 0093-5046

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5045Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5046Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5554Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5562Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32294ORIG2013-12-06
10099ORIG2013-12-06