Home Applications 090387 Application 090387
Type ANDA
Sponsor WEST-WARD PHARMS INT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML No No 002 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090387-001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 A090387-002 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090387-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2010-07-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090387-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2010-07-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 3 · 42 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Testosterone Cypionate TESTOSTERONE CYPIONATE ASCLEMED USA INC. 4efcb0be-a19b-4c6b-8a42-cd52a40d095b 2026-07-16 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Bryant Ranch Prepack ad65b1ec-433e-4524-924e-ebad09762126 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Bryant Ranch Prepack 327b4357-6948-4cd6-ad6c-e463ab8600ad 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE A-S Medication Solutions 2321a581-2e33-4233-a1d4-0711b90e3c57 2026-06-10 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE A-S Medication Solutions 7df45a8d-7d6b-4776-85e3-529527574a4f 2026-01-24 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE A-S Medication Solutions 5fb0c403-3065-498e-b910-c5988269301a 2026-01-23 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE REMEDYREPACK INC. 40a332e3-9c64-4595-91c3-dfef24f3d3bb 2025-12-19 Warnings, Adverse reactions Name fallback brand name: TESTOSTERONE CYPIONATE generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Bryant Ranch Prepack 1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b 2025-11-12 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE Alvogen Inc. ed65346b-31bc-f872-516d-78d5ab70229e 2025-10-08 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE Depo-Testosterone TESTOSTERONE CYPIONATE Pharmacia & Upjohn Company LLC cfbb53d4-b868-4a28-8436-f9112eb01c39 2025-09-29 Warnings, Adverse reactions Name fallback generic name: TESTOSTERONE CYPIONATE Depo-Testosterone TESTOSTERONE CYPIONATE Asclemed USA, Inc. 2f72be32-ede6-44d9-88a0-0653b53a3e47 2025-08-27 Warnings, Adverse reactions Name fallback generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Hospira, Inc. 6909596e-4bf7-4e11-8029-b89740a30aec 2025-08-22 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE NorthStar Rx LLC 9ced69c7-cd37-efb6-1bf9-e21c01e56f5b 2025-08-05 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE Xiromed LLC cab949ca-fde9-c5a9-5561-21e98d86d078 2025-08-05 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE AZMIRO TESTOSTERONE CYPIONATE Azurity Pharmaceuticals, Inc. 235b5625-570d-3fba-e063-6394a90aa2d1 2025-07-25 Warnings, Adverse reactions Name fallback generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Wilshire Pharmaceuticals 58ff6e0d-cc0a-4455-8254-d883d26a3b6d 2025-07-24 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE Depo-Testosterone TESTOSTERONE CYPIONATE Pharmacia & Upjohn Company LLC 735b5bf3-4464-412c-a072-1bd02f2e5380 2025-07-14 Warnings, Adverse reactions Name fallback generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE A-S Medication Solutions e9d48af3-9514-4dc5-972c-0c1f2547e5c6 2025-07-09 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Cipla USA Inc. b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478 2025-06-30 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE Testosterone Cypionate TESTOSTERONE CYPIONATE Padagis US LLC 4195516a-c8e6-457c-b805-43c9a3ca8b77 2025-06-03 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Documents# Document, Submission type, Date table Document Submission type Date 53973 ORIG 2018-05-01