FDA.reportPublic FDA data

Application 079088

Type
ANDA
Sponsor
TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISPERIDONERISPERIDONETABLET;ORAL0.25MGNoNo
002RISPERIDONERISPERIDONETABLET;ORAL0.5MGNoNo
003RISPERIDONERISPERIDONETABLET;ORAL1MGNoNo
004RISPERIDONERISPERIDONETABLET;ORAL2MGNoNo
005RISPERIDONERISPERIDONETABLET;ORAL3MGNoNo
006RISPERIDONERISPERIDONETABLET;ORAL4MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079088-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-30
A079088-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-30
A079088-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-30
A079088-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-30
A079088-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-30
A079088-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A079088-001AB
A079088-002AB
A079088-003AB
A079088-004AB
A079088-005AB
A079088-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005RISPERIDONE3MGTABLET / ORALAB2008-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006RISPERIDONE4MGTABLET / ORALAB2008-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003RISPERIDONE1MGTABLET / ORALAB2008-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004RISPERIDONE2MGTABLET / ORALAB2008-10-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079088-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079088-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079088-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079088-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079088-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079088-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079088-004AB12680178bc6a6…

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
RisperidoneRISPERIDONEPD-Rx Pharmaceuticals, Inc.e72a2768-815f-47bf-b2f9-16a93dd106842026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088
ndc (product): 43063-254
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079088
application number: ANDA079088
ndc (product): 13668-039
ndc (product): 13668-040
ndc (product): 13668-036
ndc (product): 13668-037
ndc (product): 13668-035
ndc (product): 13668-038

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 114 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6357RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6357RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6357RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6357RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6358RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6358RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6358RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6358RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6359RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6359RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6359RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6359RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6360RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6360RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6360RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6360RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6361RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6361RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6361RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6361RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6362RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6362RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6362RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
0904-6362RisperidoneRisperidoneMajor PharmaceuticalsANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-035RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-036RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-037RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-038RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-039RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
13668-040RisperidoneRisperidoneTorrent Pharmaceuticals LimitedANDACurrent
21695-072RisperidoneRisperidoneRebel Distributors CorpANDACurrent
21695-087RisperidoneRisperidoneRebel Distributors CorpANDACurrent
21695-089RisperidoneRisperidoneRebel Distributors CorpANDACurrent
21695-095RisperidoneRisperidoneRebel Distributors CorpANDACurrent
21695-096RisperidoneRisperidoneRebel Distributors CorpANDACurrent
33261-849RisperidoneRisperidoneAidarex Pharmaceuticals LLCANDACurrent
43063-254RisperidoneRisperidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-254RisperidoneRisperidonePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23928ORIG2008-11-25