Application 018276

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XANAXALPRAZOLAMTABLET;ORAL0.25MGYesNo
002XANAXALPRAZOLAMTABLET;ORAL0.5MGYesNo
003XANAXALPRAZOLAMTABLET;ORAL1MGYesYes
004XANAXALPRAZOLAMTABLET;ORAL2MGYesNo

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

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
N018276-001XANAXALPRAZOLAM0.25MGTABLET / ORALABRLD, Approved before 1982
N018276-002XANAXALPRAZOLAM0.5MGTABLET / ORALABRLD, Approved before 1982
N018276-003XANAXALPRAZOLAM1MGTABLET / ORALABRLD, RS, Approved before 1982
N018276-004XANAXALPRAZOLAM2MGTABLET / ORALABRLD1985-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018276-001AB
N018276-002AB
N018276-003AB
N018276-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-004XANAX2MGTABLET / ORALABRLD1985-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-004XANAX2MGTABLET / ORALABRLD1985-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-004XANAX2MGTABLET / ORALABRLD1985-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-004XANAX2MGTABLET / ORALABRLD1985-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-004XANAX2MGTABLET / ORALABRLD1985-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-004AB1d06236e962d9…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMMylan Pharmaceuticals Inc.13930c94-d83a-414f-be35-b1fef35f738d2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 59762-3720
ndc (product): 59762-3721
ndc (product): 59762-3719
ndc (product): 59762-3722
XanaxALPRAZOLAMViatris Specialty LLCbb5cf72e-3a41-41a8-9a38-80f974eca33f2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMAsclemed USA, Inc.e3245259-024f-4bd9-9ec6-94aa11febfd72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LP60c90b4b-174f-4fd2-b65f-fc166c16bdc12023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LP10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc2023-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 71205-614
XanaxALPRAZOLAMPHARMACIA & UPJOHN COMPANY LLC388e249d-b9b6-44c3-9f8f-880eced0239f2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 0009-0090
ndc (product): 0009-0055
ndc (product): 0009-0029
ndc (product): 0009-0094
AlprazolamALPRAZOLAMProficient Rx LP4579facb-b225-4108-a5ef-dada926ef7cf2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 71205-652
AlprazolamALPRAZOLAMProficient Rx LPf6990b57-7011-4cdf-8abc-1794e2e0c7f12019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 63187-971
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC964d7f43-34a6-45af-a95f-3b9ade17c6a52018-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
ndc (product): 67544-414
ndc (product): 67544-415
ndc (product): 67544-347

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
50090-4950AlprazolamalprazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4950AlprazolamalprazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
53002-0340AlprazolamalprazolamRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
53002-0340AlprazolamalprazolamRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
63187-971AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-971AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
63629-3308AlprazolamalprazolamBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67046-963AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67046-964AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67046-965AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67544-347AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
67544-414AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
67544-415AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
70518-2785AlprazolamalprazolamREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2785AlprazolamalprazolamREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71205-614AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-652AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73417SUPPL 2023-02-08
73234SUPPL2023-01-17
73233SUPPL2023-01-17
73174SUPPL2023-01-17
73173SUPPL2023-01-17
66455SUPPL2021-03-02
66448SUPPL2021-03-02
66190SUPPL2021-02-11
66189SUPPL2021-02-11
66131SUPPL2021-02-09
46632SUPPL2016-12-30
46465SUPPL2016-12-22
46243SUPPL2016-12-20
886SUPPL2011-08-26
11189SUPPL2011-08-24
33466SUPPL2011-06-07
885SUPPL2011-06-03
40793SUPPL2006-10-25
40792SUPPL2006-10-25
40791SUPPL2006-10-25
14963SUPPL2004-04-07
884SUPPL2004-04-07
20121SUPPL1997-11-20