Home Applications 019039 Application 019039
Type NDA
Sponsor PHARMALUCENCE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CIS-PYRO TECHNETIUM TC-99M PYROPHOSPHATE KIT INJECTABLE;INJECTION N/A No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019039-001 CIS-PYRO TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A INJECTABLE / INJECTION AP 1987-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019039-001 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 · 42 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 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45567-0060 Kit for the Preparation of Technetium Tc99m Pyrophosphate Technetium Tc99m Pyrophosphate Pharmalucence, Inc. NDA Current 45567-0060 Kit for the Preparation of Technetium Tc99m Pyrophosphate Technetium Tc99m Pyrophosphate Sun Pharmaceutical Industries, Inc. NDA Current 45567-0060 Kit for the Preparation of Technetium Tc99m Pyrophosphate Technetium Tc99m Pyrophosphate Pharmalucence, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82419 SUPPL 2025-06-02 82328 SUPPL 2025-05-27 1214 SUPPL 2002-02-27