FDA.reportPublic FDA data

Application 074909

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET;ORAL2MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074909-001ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074909-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074909-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 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): 074909
application number: ANDA074909
ndc (product): 50090-2819
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed32025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
ndc (product): 55289-523
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
ndc (product): 0781-1089
AlprazolamALPRAZOLAMBryant Ranch Prepackb0000772-2514-45a2-a75d-1bbb13c299892024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
ndc (product): 71335-0920
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
ndc (product): 63187-444

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
0781-1089AlprazolamAlprazolamSandoz IncANDACurrent
21695-250AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
50090-2819AlprazolamAlprazolamA-S Medication SolutionsANDACurrent
55289-523AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-523AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-523AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-523AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-523AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-862ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
63187-444AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-444AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-444AlprazolamAlprazolamProficient Rx LPANDACurrent
66267-564AlprazolamAlprazolamNuCare Pharmaceuticals,Inc.ANDACurrent
66267-564AlprazolamAlprazolamNuCare Pharmaceuticals,Inc.ANDACurrent
71335-0920AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0920AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0920AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0920AlprazolamAlprazolamBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22381ORIG1998-03-25