Home Applications 078520 Application 078520
Type ANDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM INJECTABLE;INJECTION 30MG/10ML (3MG/ML) No No 002 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM INJECTABLE;INJECTION 90MG/10ML (9MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078520-001 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 A078520-002 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31
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 · 86 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 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67457-430 Pamidronate Disodium Pamidronate Disodium Mylan Institutional LLC ANDA Current 67457-446 Pamidronate Disodium Pamidronate Disodium Mylan Institutional LLC ANDA Current 82449-800 Pamidronate Disodium Pamidronate Disodium Steriscience Specialties Private Limited ANDA Current 82449-801 Pamidronate Disodium Pamidronate Disodium Steriscience Specialties Private Limited ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23912 ORIG 2008-11-25