Home Applications 086030 Application 086030
Type ANDA
Sponsor WATSON PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A086030-001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086030-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO Approved before 1982 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 · 41 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Depo-Testosterone TESTOSTERONE CYPIONATE Pharmacia & Upjohn Company LLC cfbb53d4-b868-4a28-8436-f9112eb01c39 2026-08-21 Warnings, Adverse reactions Name fallback generic name: TESTOSTERONE CYPIONATE testosterone cypionate TESTOSTERONE CYPIONATE Alvogen Inc. ed65346b-31bc-f872-516d-78d5ab70229e 2026-08-19 Warnings, Adverse reactions Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE 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 Bryant Ranch Prepack 1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b 2025-11-12 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate 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 Testosterone Cypionate TESTOSTERONE CYPIONATE Eugia US LLC f901e2b2-f143-4237-8e95-0d134585490b 2025-06-03 Warnings, Adverse reactions Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55045-2092 Testosterone Cypionate Testosterone Cypionate Dispensing Solutions, Inc. ANDA Current