Home Applications 021008 Application 021008
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SANDOSTATIN LAR OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 10MG BASE/VIAL Yes No 002 SANDOSTATIN LAR OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 20MG BASE/VIAL Yes No 003 SANDOSTATIN LAR OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 30MG BASE/VIAL Yes Yes
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 N021008-001 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 N021008-002 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 N021008-003 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0647 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0647 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0648 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0811 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0818 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0825 Sandostatin LAR Depot octreotide acetate Novartis Pharmaceuticals Corporation NDA Current