Home Applications 077433 Application 077433
Type ANDA
Sponsor AREVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM INJECTABLE;INJECTION 30MG/VIAL No No 002 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM INJECTABLE;INJECTION 60MG/VIAL No No 003 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM INJECTABLE;INJECTION 90MG/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077433-001 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 A077433-002 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 A077433-003 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26
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 4 · 123 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 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077433-002 PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE / INJECTION 2008-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077433-003 PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077433-001 PAMIDRONATE DISODIUM 30MG/VIAL INJECTABLE / INJECTION AP 2008-11-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59923-601 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-601 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-601 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-602 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-602 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-602 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-603 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-603 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current 59923-603 Pamidronate Disodium Pamidronate Disodium Areva Pharmaceuticals Inc. ANDA Current