Application 090834

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLNoNo
002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.1MG BASE/MLNoNo
003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.5MG BASE/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12
A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12
A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)OCTREOTIDE ACETATEEQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090834-001AP
A090834-002AP
A090834-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-002OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.1MG BASE/MLINJECTABLE / INJECTIONAP2013-11-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-003OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.5MG BASE/MLINJECTABLE / INJECTIONAP2013-11-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090834-001OCTREOTIDE ACETATE (PRESERVATIVE FREE)EQ 0.05MG BASE/MLINJECTABLE / INJECTIONAP2013-11-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090834-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090834-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090834-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090834-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090834-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090834-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090834-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090834-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090834-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090834-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090834-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090834-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090834-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090834-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090834-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090834-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090834-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090834-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090834-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090834-001AP18072bd15b7f6…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SandostatinOCTREOTIDE ACETATENovartis Pharmaceuticals Corporation4e2c9856-1836-49f0-9472-4dbeeb408f392026-07-22Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEGLENMARK PHARMACEUTICALS INC., USA387d7f8d-9762-4f6b-99e1-bdc50b8a16332026-01-30Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATEOCTREOTIDE ACETATEMylan Institutional LLCe5c21813-4714-4f23-be8b-765bd58f63b32026-01-21Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Sandostatin LAR DepotOCTREOTIDE ACETATENovartis Pharmaceuticals Corporationd0b7fe9e-7000-4b79-ba3b-291ce92c14f92025-12-22Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATEOCTREOTIDE ACETATEHainan Shuangcheng Pharmaceuticals Co., Ltd.ab9b0d3d-4dab-4c5b-9c23-3a14f8fcfcde2025-06-25Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
BYNFEZIA PenOCTREOTIDE ACETATESun Pharmaceutical Industries, Inc.20ed4e79-ad4c-426f-859d-83790c00439b2025-02-21Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEMeitheal Pharmaceuticals, Inc.01962c67-e551-47b6-a276-e1ae1860d2a42025-01-16Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATEOCTREOTIDE ACETATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ffaf9462-cdd8-433b-8b03-464a35577fe92024-12-03Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATETeva Pharmaceuticals, Inc.d9739ea6-74de-4a41-a806-6e827a23cedb2024-07-30Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited884e4287-a4d8-4a6e-8d99-dbe5e88875b92024-07-29Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited2344ae7a-c2f0-433b-9133-1dcb16bb18a02024-07-25Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEMylan Institutional LLC2d78d5d1-77b2-4da1-98d4-d9c36e743ce22024-07-15Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
OctreotideOCTREOTIDE ACETATEFresenius Kabi USA, LLCd6a9a800-889d-417f-b533-1913197d00222024-05-23Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
OctreotideOCTREOTIDE ACETATEFresenius Kabi USA, LLCf278f0d8-4062-420a-97c3-3a8b88253a082024-05-07Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEHikma Pharmaceuticals USA Inc.9502860d-0261-4d69-a4be-827a5376d3562024-03-01Warnings, Adverse reactionsName fallback
generic name: OCTREOTIDE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-451Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-451Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-451Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-451Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-452Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-452Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-452Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-452Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-453Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-453Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-453Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-453Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-463Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-464Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent
25021-465Octreotide Acetateoctreotide acetateSagent PharmaceuticalsANDACurrent