LIRAGLUTIDE
EMERGE BIOSCIENCE · LIRAGLUTIDE
Open FDA's page for this record- Application number
- ANDA218115
- Sponsor name
- EMERGE BIOSCIENCE
- Submissions
- Submission type
- SUPPL
- Submission number
- 3
- Submission status
- AP
- Submission status date
- 20251015
- Review priority
- STANDARD
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20250402
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- LIRAGLUTIDE
- Reference standard
- No
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Te code
- AP1
- Active ingredients
- Name
- LIRAGLUTIDE
- Strength
- 18MG/3ML (6MG/ML)
- Harmonized identifiers (openFDA)
- Application number
- ANDA218115
- Brand name
- LIRAGLUTIDE
- Generic name
- LIRAGLUTIDE
- Manufacturer name
- Meitheal Pharmaceuticals Inc., NorthStar Rx LLC
- Product NDC
- 71288-563, 72603-745
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- LIRAGLUTIDE
- RxCUI
- 897122
- SPL ID
- a0bb0116-f90a-490b-9ca9-5bcd6210c763, 792c7fe2-ae5a-4867-a4de-8147efacc85e
- SPL set ID
- 0efc3a89-211a-4496-baab-e8265e07de2b, 4253be3b-bda6-4efd-8118-9c9538168a88
- Package NDC
- 71288-563-84, 71288-563-85, 72603-745-01, 72603-745-03, 72603-745-02
- Nui
- N0000178480, M0160181, N0000020058
- Pharm class epc
- GLP-1 Receptor Agonist [EPC]
- Pharm class cs
- Glucagon-Like Peptide 1 [CS]
- Pharm class moa
- Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- UNII
- 839I73S42A