Application 074174

Type
ANDA
Sponsor
DAVA INTL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.25MGNoNo
002ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.5MGNoNo
003ALPRAZOLAMALPRAZOLAMTABLET;ORAL1MGNoNo
004ALPRAZOLAMALPRAZOLAMTABLET;ORAL2MGNoNo

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
A074174-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19
A074174-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19
A074174-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1993-10-19
A074174-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1993-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074174-001AB
A074174-002AB
A074174-003AB
A074174-004AB

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 UTC2026-02A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074174-001ALPRAZOLAM0.25MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-002ALPRAZOLAM0.5MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-003ALPRAZOLAM1MGTABLET / ORALAB1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-004ALPRAZOLAM2MGTABLET / ORALAB1993-10-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074174-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074174-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074174-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074174-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074174-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074174-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074174-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074174-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074174-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074174-004AB1d06236e962d9…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMANI Pharmaceuticals, Inc.38428a1b-718c-49cc-94ae-2e3644ba62562023-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074174
application number: ANDA074174

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 141 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-118AlprazolamAlprazolamBlenheim Pharmacal, Inc.ANDACurrent
10544-155AlprazolamAlprazolamBlenheim Pharmacal, Inc.ANDACurrent
33261-004AlprazolamAlprazolamAidarex Pharmaceuticals LLCANDACurrent
33261-005AlprazolamAlprazolamAidarex Pharmaceuticals LLCANDACurrent
33261-500AlprazolamAlprazolamAidarex Pharmaceuticals LLCANDACurrent
33261-594AlprazolamAlprazolamAidarex Pharmaceuticals LLCANDACurrent
43063-364AlprazolamAlprazolamPD-Rx Pharmaceuticals, InANDACurrent
43063-364AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-364AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-364AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-364AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-367AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-367AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-367AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-367AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-367AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-370AlprazolamAlprazolamPD-Rx Pharmaceuticals, InANDACurrent
43063-370AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-370AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-370AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-370AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-828AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-828AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-828AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1759AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-1759AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2256AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2256AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2346AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
50090-2425AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
53002-4180AlprazolamAlprazolamRPK Pharmaceuticals, Inc.ANDACurrent
53002-4180AlprazolamAlprazolamRPK Pharmaceuticals, Inc.ANDACurrent
55700-312AlprazolamAlprazolamQuality Care Products, LLCANDACurrent
55700-312AlprazolamAlprazolamQuality Care Products, LLCANDACurrent
55700-312AlprazolamAlprazolamQuality Care Products, LLCANDACurrent
55700-313AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-313AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-313AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-622AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-622AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-671AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-671AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-671AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-504AlprazolamalprazolamGolden State Medical Supply, Inc.ANDACurrent
60429-504AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
60429-504AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
60429-504AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
60429-504AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
60429-505AlprazolamalprazolamGolden State Medical Supply, Inc.ANDACurrent
60429-505AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
60429-505AlprazolamAlprazolamGolden State Medical Supply IncANDACurrent
61919-836ALPRAZOLAMALPRAZOLAMDirect RxANDACurrent
61919-836ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-836ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-836ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-849ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-849ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-849ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-849ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
63629-7726AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-7726AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-7726AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-8164AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-8172AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-8172AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
63629-8214AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
67046-959AlprazolamAlprazolamContract Pharmacy Services-PAANDACurrent
67046-969AlprazolamAlprazolamContract Pharmacy Services-PAANDACurrent
67046-970AlprazolamAlprazolamContract Pharmacy Services-PAANDACurrent
67253-900AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-900AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-900AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-900AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-901AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-901AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-901AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-901AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-902AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-902AlprazolamAlprazolamPar PharmaceuticalANDACurrent
67253-902AlprazolamAlprazolamPar PharmaceuticalANDACurrent