Home Applications 075196 Application 075196
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALPROSTADIL ALPROSTADIL INJECTABLE;INJECTION 0.5MG/ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075196-001 ALPROSTADIL ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075196-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075196-001 ALPROSTADIL 0.5MG/ML INJECTABLE / INJECTION AP 1999-04-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alprostadil ALPROSTADIL Meitheal Pharmaceuticals Inc. 35d229e1-6947-435c-bf54-bfa09cca7e53 2024-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075196 application number: ANDA075196
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-1501 Alprostadil Alprostadil Teva Parenteral Medicines, Inc. ANDA Current 0703-1501 Alprostadil Alprostadil Teva Parenteral Medicines, Inc. ANDA Current 0703-1501 Alprostadil Alprostadil Teva Parenteral Medicines, Inc. ANDA Current 0703-1501 Alprostadil Alprostadil Teva Parenteral Medicines, Inc. ANDA Current