FDA.reportPublic FDA data

Application 078491

Type
ANDA
Sponsor
OXFORD PHARMS

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
A078491-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL2008-09-25
A078491-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL2008-09-25
A078491-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL2008-09-25
A078491-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL2008-12-12

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 22:54:322026-06A078491-001ALPRAZOLAM0.25MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-002ALPRAZOLAM0.5MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-003ALPRAZOLAM1MGTABLET / ORAL2008-09-25a50c72e98297…
2026-08-01 22:54:322026-06A078491-004ALPRAZOLAM2MGTABLET / ORAL2008-12-12a50c72e98297…

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 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMClinical Solutions Wholesale, LLC0cf8b567-201b-44fa-8fd3-c74023aff44f2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.4203d3fe-916e-41af-9daf-f58f4fed6f9c2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMSt. Mary's Medical Park Pharmacyfc5fe795-6b41-aecf-e053-6394a90af5622026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepack68d8b8d1-00a4-42c4-a796-90211fee1a6d2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepackaaab422d-c763-4352-8ffc-5aafdf91e8dd2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepack0dce8232-0b0e-4f81-af95-36e6febdb5502026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMCoupler LLC5111e57d-8920-6861-e063-6294a90a21942026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMASCLEMED USA INC.8d76a554-7ed1-4c93-a5ea-30898aec0aa12026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMCoupler LLC509a8a86-d61c-3f05-e063-6394a90a52ca2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMPar Health USA, LLCff1630b4-2044-433c-96bc-0bb4ae8d42a02026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepack2bd0d4c6-0fde-46f2-bb13-da25d50427df2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepackd8364af1-d23e-4cd7-9a81-077ae97a951a2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMBryant Ranch Prepack0e2644fa-8334-4209-a63d-2466b5ab55b42026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMProficient Rx LPc6795ed8-af28-41f4-b85b-48e1fe9d03692026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMPreferredPharmaceuticals Inc.dc130aae-4510-4de7-a750-4a144e88208d2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.73c1d1dc-ade2-4bb4-b109-83bd63acd15c2026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.78682252-e448-4b20-b49d-27c2c70e4cb32026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMA-S Medication Solutions8ef75d22-4a7c-48d5-a532-5a43b8593e7c2026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMNatco Pharma USA LLCb3c55877-2538-4892-bdb1-d618c643d29c2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM
AlprazolamALPRAZOLAMNorthwind Health Company, LLC25174ee5-a86e-ab97-e063-6394a90acd872025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Alprazolam
generic name: ALPRAZOLAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-424AlprazolamalprazolamMedsource PharmaceuticalsANDACurrent
61919-006ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-379ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-379ALPRAZOLAMALPRAZOLAMDirect_RxANDACurrent
61919-447ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
61919-447ALPRAZOLAMALPRAZOLAMDIRECT RXANDACurrent
66336-932AlprazolamalprazolamDispensing Solutions, Inc.ANDACurrent