FDA.reportPublic FDA data

Application 090387

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATEINJECTABLE;INJECTION100MG/MLNoNo
002TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATEINJECTABLE;INJECTION200MG/MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090387-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2010-07-15
A090387-002TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2010-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090387-001AO
A090387-002AO

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 22:54:322026-06A090387-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2010-07-15a50c72e98297…
2026-08-01 22:54:322026-06A090387-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2010-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090387-001AO1a50c72e98297…
2026-08-01 22:54:322026-06A090387-002AO1a50c72e98297…

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Testosterone CypionateTESTOSTERONE CYPIONATEASCLEMED USA INC.4efcb0be-a19b-4c6b-8a42-cd52a40d095b2026-07-16Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepackad65b1ec-433e-4524-924e-ebad097621262026-07-14Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack327b4357-6948-4cd6-ad6c-e463ab8600ad2026-07-14Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEA-S Medication Solutions2321a581-2e33-4233-a1d4-0711b90e3c572026-06-10Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutions7df45a8d-7d6b-4776-85e3-529527574a4f2026-01-24Warnings, Adverse reactionsName fallback
brand name: testosterone cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEA-S Medication Solutions5fb0c403-3065-498e-b910-c5988269301a2026-01-23Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATEREMEDYREPACK INC.40a332e3-9c64-4595-91c3-dfef24f3d3bb2025-12-19Warnings, Adverse reactionsName fallback
brand name: TESTOSTERONE CYPIONATE
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b2025-11-12Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
testosterone cypionateTESTOSTERONE CYPIONATEAlvogen Inc.ed65346b-31bc-f872-516d-78d5ab70229e2025-10-08Warnings, Adverse reactionsName fallback
brand name: testosterone cypionate
generic name: TESTOSTERONE CYPIONATE
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLCcfbb53d4-b868-4a28-8436-f9112eb01c392025-09-29Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE CYPIONATE
Depo-TestosteroneTESTOSTERONE CYPIONATEAsclemed USA, Inc.2f72be32-ede6-44d9-88a0-0653b53a3e472025-08-27Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEHospira, Inc.6909596e-4bf7-4e11-8029-b89740a30aec2025-08-22Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
testosterone cypionateTESTOSTERONE CYPIONATENorthStar Rx LLC9ced69c7-cd37-efb6-1bf9-e21c01e56f5b2025-08-05Warnings, Adverse reactionsName fallback
brand name: testosterone cypionate
generic name: TESTOSTERONE CYPIONATE
testosterone cypionateTESTOSTERONE CYPIONATEXiromed LLCcab949ca-fde9-c5a9-5561-21e98d86d0782025-08-05Warnings, Adverse reactionsName fallback
brand name: testosterone cypionate
generic name: TESTOSTERONE CYPIONATE
AZMIROTESTOSTERONE CYPIONATEAzurity Pharmaceuticals, Inc.235b5625-570d-3fba-e063-6394a90aa2d12025-07-25Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEWilshire Pharmaceuticals58ff6e0d-cc0a-4455-8254-d883d26a3b6d2025-07-24Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
Depo-TestosteroneTESTOSTERONE CYPIONATEPharmacia & Upjohn Company LLC735b5bf3-4464-412c-a072-1bd02f2e53802025-07-14Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE CYPIONATE
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutionse9d48af3-9514-4dc5-972c-0c1f2547e5c62025-07-09Warnings, Adverse reactionsName fallback
brand name: testosterone cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATECipla USA Inc.b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4782025-06-30Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE
Testosterone CypionateTESTOSTERONE CYPIONATEPadagis US LLC4195516a-c8e6-457c-b805-43c9a3ca8b772025-06-03Warnings, Adverse reactionsName fallback
brand name: Testosterone Cypionate
generic name: TESTOSTERONE CYPIONATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53973ORIG2018-05-01