FDA.reportPublic FDA data

Application 077331

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCTREOTIDE ACETATEOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077331-001OCTREOTIDE ACETATEOCTREOTIDE ACETATEEQ 1MG BASE/MLINJECTABLE / INJECTION2008-03-04

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A077331-001OCTREOTIDE ACETATEEQ 1MG BASE/MLINJECTABLE / INJECTION2008-03-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077331-001OCTREOTIDE ACETATEEQ 1MG BASE/MLINJECTABLE / INJECTION2008-03-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077331-001OCTREOTIDE ACETATEEQ 1MG BASE/MLINJECTABLE / INJECTION2008-03-04a50c72e98297…

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
brand name: Octreotide Acetate
generic name: OCTREOTIDE ACETATE
OCTREOTIDE ACETATEOCTREOTIDE ACETATEMylan Institutional LLCe5c21813-4714-4f23-be8b-765bd58f63b32026-01-21Warnings, Adverse reactionsName fallback
brand name: OCTREOTIDE ACETATE
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
brand name: OCTREOTIDE ACETATE
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
brand name: Octreotide Acetate
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
brand name: OCTREOTIDE ACETATE
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATETeva Pharmaceuticals, Inc.d9739ea6-74de-4a41-a806-6e827a23cedb2024-07-30Warnings, Adverse reactionsName fallback
brand name: Octreotide Acetate
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited884e4287-a4d8-4a6e-8d99-dbe5e88875b92024-07-29Warnings, Adverse reactionsName fallback
brand name: Octreotide Acetate
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEGland Pharma Limited2344ae7a-c2f0-433b-9133-1dcb16bb18a02024-07-25Warnings, Adverse reactionsName fallback
brand name: Octreotide Acetate
generic name: OCTREOTIDE ACETATE
Octreotide AcetateOCTREOTIDE ACETATEMylan Institutional LLC2d78d5d1-77b2-4da1-98d4-d9c36e743ce22024-07-15Warnings, Adverse reactionsName fallback
brand name: Octreotide Acetate
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
brand name: Octreotide Acetate
generic name: OCTREOTIDE ACETATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.