Home Applications 075957 Application 075957
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML No No 002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.1MG BASE/ML No No 003 OCTREOTIDE ACETATE OCTREOTIDE ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML 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 A075957-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 A075957-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 A075957-003 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03
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 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-3301 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3301 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3301 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3301 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3311 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3311 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3311 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3311 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3321 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3321 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3321 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 0703-3321 Octreotide Acetate Octreotide Acetate Teva Parenteral Medicines, Inc. ANDA Current 63629-8831 Octreotide Acetate Octreotide Acetate Bryant Ranch Prepack ANDA Current 63629-8831 Octreotide Acetate Octreotide Acetate Bryant Ranch Prepack ANDA Current