Application 074112

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.25MGNoNo
002ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.5MGNoNo
003ALPRAZOLAMALPRAZOLAMTABLET;ORAL1MGNoNo

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

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
A074112-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29
A074112-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29
A074112-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1995-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074112-001AB
A074112-002AB
A074112-003AB

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074112-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074112-001AB18072bd15b7f6…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions3c0cb60f-1c3a-48a6-ad16-f143515484122025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 50090-2896
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.0ffcdbab-17e4-4395-8155-5b6ad00be6c22025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 43063-609
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMREMEDYREPACK INC.563e09db-2f3d-4ce8-b356-ae44477be6d02024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAdvanced Rx Pharmacy of Tennessee, LLCb39e2bc8-b691-0f4e-e053-2995a90a00fd2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 0781-1079
ndc (product): 0781-1077
ndc (product): 0781-1061
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLCf95f4030-e8e0-416f-951d-c4dac09f386a2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC54c790c5-2e6c-439d-8e3b-7502c962a5962023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 63187-225
ndc (product): 63187-443
AlprazolamALPRAZOLAMProficient Rx LP447efe78-3696-481c-bbae-23199a39ec942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 63187-916

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
0615-7999AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7999AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8000AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8000AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1061AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1077AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
0781-1079AlprazolamAlprazolamSandoz IncANDACurrent
10544-104AlprazolamAlprazolamBlenheim Pharmacal, Inc.ANDACurrent
21695-247AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
21695-248AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
21695-249AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
35356-744AlprazolamAlprazolamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-744AlprazolamAlprazolamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-744AlprazolamAlprazolamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-744AlprazolamAlprazolamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, InANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-609AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-521AlprazolamAlprazolamMedsource PharmaceuticalsANDACurrent
45865-521AlprazolamAlprazolamMedsource PharmaceuticalsANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-032AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-039AlprazolamALPRAZOLAMLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2781AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2781AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2896AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50436-4635AlprazolamAlprazolamUnit Dose ServicesANDACurrent
50436-4636AlprazolamAlprazolamUnit Dose ServicesANDACurrent
53002-3952AlprazolamAlprazolamRPK Pharmaceuticals, Inc.ANDACurrent
55154-4979AlprazolamAlprazolamCardinal HealthANDACurrent
55154-4979AlprazolamAlprazolamCardinal HealthANDACurrent
60760-813AlprazolamAlprazolamSt. Marys Medical Park PharmacyANDACurrent
60760-813AlprazolamAlprazolamSt. Marys Medical Park PharmacyANDACurrent
61919-005ALPRAZOLAMALPRAZOLAMDirect RxANDACurrent
61919-005ALPRAZOLAMALPRAZOLAMDirect RxANDACurrent
61919-089XANAXALPRAZOLAMDIRECT RXANDACurrent
61919-089XANAXALPRAZOLAMDirect_RxANDACurrent
61919-089XANAXALPRAZOLAMDirect_RxANDACurrent
61919-089ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-089ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-576ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-576ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
63187-225AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-225AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-225AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-443AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-443AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-443AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-916AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-916AlprazolamAlprazolamProficient Rx LPANDACurrent
63739-644AlprazolamAlprazolamMcKesson CorporationANDACurrent
63739-644AlprazolamAlprazolamMcKesson Corporation dba SKY PackagingANDACurrent
63739-669AlprazolamAlprazolamMcKesson CorporationANDACurrent
63739-669AlprazolamAlprazolamMcKesson Corporation dba SKY PackagingANDACurrent
63739-674AlprazolamAlprazolamMcKesson CorporationANDACurrent
63739-674AlprazolamAlprazolamMcKesson Corporation dba SKY PackagingANDACurrent
66267-013AlprazolamAlprazolamNuCare Pharmaceuticals, Inc.ANDACurrent