Application 017078

Type
NDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MGYesNo
002DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGYesNo
003DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL15MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017078-001DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982
N017078-002DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982
N017078-003DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017078-001AB
N017078-002AB
N017078-003AB

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017078-003DEXEDRINE15MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017078-001DEXEDRINE5MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017078-002DEXEDRINE10MGCAPSULE, EXTENDED RELEASE / ORALABRLD, Approved before 1982c0c555d07b60…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N017078-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N017078-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N017078-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08N017078-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N017078-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N017078-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N017078-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017078-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017078-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017078-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017078-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017078-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017078-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017078-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017078-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017078-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017078-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017078-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017078-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017078-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017078-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017078-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017078-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017078-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017078-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017078-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017078-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017078-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017078-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017078-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017078-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017078-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017078-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017078-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017078-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017078-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017078-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017078-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017078-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017078-001AB179d66fd596c7…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATEAmneal Pharmaceuticals LLCcc717b9b-22ea-4c60-a1d4-ee38a40bce782025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017078
application number: NDA017078
ndc (product): 64896-675
ndc (product): 64896-673
ndc (product): 64896-674
Dextroamphetamine Sulfate Extended-ReleaseDEXTROAMPHETAMINE SULFATEAmneal Pharmaceuticals of New York LLC2ec5c30f-4eb8-48a5-83c4-2364504134642023-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017078
application number: NDA017078
ndc (product): 0115-9929
ndc (product): 0115-9927
ndc (product): 0115-9928

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
52054-512DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
52054-513DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
52054-514DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
54505-327Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
54505-328Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
54505-329Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83456SUPPL 2025-09-25
83455SUPPL 2025-09-25
83423SUPPL 2025-09-24
75784SUPPL 2023-10-17
75770SUPPL 2023-10-16
70327SUPPL2022-03-01
70326SUPPL2022-03-01
70285SUPPL2022-02-28
57313SUPPL2019-01-22
57225SUPPL2019-01-16
57224SUPPL2019-01-16
56340SUPPL2018-11-08
48506SUPPL2017-05-24
48481SUPPL2017-05-22
46775SUPPL2017-01-10
46716SUPPL2017-01-06
13081SUPPL2015-04-20
10960SUPPL2015-04-20
10959SUPPL2013-12-12
542SUPPL2013-12-10
10958SUPPL2013-06-18
541SUPPL2013-06-13
33224SUPPL2008-06-12
13080SUPPL2008-05-28
44010ORIG2007-05-18
33223SUPPL2007-05-07
540SUPPL2007-05-07
539SUPPL2006-08-14
10957SUPPL2006-08-11