FDA.reportPublic FDA data

Application 217590

Type
ANDA
Sponsor
ORBICULAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIRAGLUTIDELIRAGLUTIDESOLUTION;SUBCUTANEOUS18MG/3ML (6MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A217590-001LIRAGLUTIDELIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217590-001AP1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14c2088c7a36db…
2026-09-14 22:38:342026-08A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-1484e616aacf4f…
2026-08-18 06:07:402026-07A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217590-001LIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP12026-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A217590-001AP11c2088c7a36db…
2026-09-14 22:38:342026-08A217590-001AP1184e616aacf4f…
2026-08-18 06:07:402026-07A217590-001AP11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217590-001AP11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217590-001AP11a50c72e98297…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LiraglutideLIRAGLUTIDEMeitheal Pharmaceuticals Inc.0efc3a89-211a-4496-baab-e8265e07de2b2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDENorthStar Rx LLC4253be3b-bda6-4efd-8118-9c9538168a882026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
liraglutideLIRAGLUTIDECipla USA Inc.22c86976-9657-4dd0-8fff-0c3f3f08357c2026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEHikma Pharmaceuticals USA Inc.2100ec49-57b2-4330-ab5f-057ce9b7e4d02026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDETeva Pharmaceuticals, Inc.625ac780-70a9-41e4-a892-bcba0f803f1c2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
SaxendaLIRAGLUTIDENovo Nordisk Pharmaceutical Industries, LP3946d389-0926-4f77-a708-0acb8153b1432026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDETeva Pharmaceuticals USA, Inc.14bf9812-14ee-46ce-93b1-686e4906cbbc2026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDELupin Pharmaceuticals, Inc.0450d8a2-a88e-4849-9788-ed4f5246f2232025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEBiocon Pharma Inc.0b898330-eca1-f60a-71d2-b91716e336ed2025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
VictozaLIRAGLUTIDENovo Nordisk5a9ef4ea-c76a-4d34-a604-27c5b505f5a42025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEBiocon Pharma Inc.cb032379-043b-443c-d552-b5d25f27f3c42025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEA-S Medication Solutions0ba917f7-b974-4364-a745-7494ecae3e732025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEHybio Pharmaceutical Co., Ltd. (Pingshan Factory)1a372465-d56b-2b80-e063-6394a90a33042024-12-03Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEHybio Pharmaceutical Co., Ltd. (Pingshan Factory)1a36f43f-d734-97cc-e063-6294a90ae0da2024-12-02Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
LiraglutideLIRAGLUTIDEHybio Pharmaceutical Co., Ltd. (Pingshan Factory)1a36b801-41e2-2eed-e063-6294a90a6f272024-06-05Warnings, Adverse reactionsName fallback
brand name: Liraglutide
generic name: LIRAGLUTIDE
SaxendaLIRAGLUTIDEA-S Medication Solutions7b11f6ac-4c27-4748-9e65-22d4cf3adfb42024-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIRAGLUTIDE
VictozaLIRAGLUTIDEA-S Medication Solutions1d18f106-0584-4fee-97ab-32771a64b8092023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIRAGLUTIDE
VictozaLIRAGLUTIDEA-S Medication Solutions35e613e3-7aae-4152-b827-99d1ee7841be2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIRAGLUTIDE

Reported adverse events (FAERS/openFDA)#

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