Home Applications 019667 Application 019667
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML Yes Yes 002 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML Yes Yes 003 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML Yes Yes 004 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.2MG BASE/ML Yes Yes 005 SANDOSTATIN OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 1MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019667-001 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-002 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-003 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-004 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 N019667-005 SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12
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 6 · 210 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 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 134 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 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0180 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0181 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0182 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0183 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0183 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0078-0184 Sandostatin octreotide acetate Novartis Pharmaceuticals Corporation NDA Current 0781-3164 Octreotide Acetate Octreotide Acetate Sandoz Inc NDA Current 0781-3165 Octreotide Acetate Octreotide Acetate Sandoz Inc NDA Current 0781-3166 Octreotide Acetate Octreotide Acetate Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-3167 Octreotide Acetate Octreotide Acetate Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-3168 Octreotide Acetate Octreotide Acetate Sandoz Inc NDA AUTHORIZED GENERIC Current