Approvals (Drugs@FDA)

OSENVELT, STOBOCLO

CELLTRION INC · DENOSUMAB-BMWO

2025-10-29BLA761404Biologic (BLA)Prescription

Open FDA's page for this record

Application number

BLA761404

Sponsor name

CELLTRION INC

Submissions

Submission type
SUPPL
Submission number
3
Submission status
AP
Submission status date
20250910
Review priority
STANDARD
Submission class code
LABELING
Submission class code description
Labeling
Application docs
1. ID
  83328
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s003ltr.pdf
  Date
  20251103
  Type
  Letter
2. ID
  83361
  Url
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s003lbl.pdf
  Date
  20250917
  Type
  Label
3. ID
  84059
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s003ltr.pdf
  Date
  20251104
  Type
  Letter
Submission type
ORIG
Submission number
1
Submission status
AP
Submission status date
20250228
Review priority
STANDARD
Submission class code
UNKNOWN
Application docs
1. ID
  81384
  Url
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000lbledt.pdf
  Date
  20250228
  Type
  Label
2. ID
  81434
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s000ltr.pdf
  Date
  20250306
  Type
  Letter
3. ID
  81505
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000Orig2lbl.pdf
  Date
  20250310
  Type
  Label
4. ID
  83973
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761404Orig1s000TOC.html
  Date
  20251029
  Type
  Review
Submission type
ORIG
Submission number
2
Submission status
AP
Submission status date
20251029
Review priority
STANDARD
Submission class code
EFFICACY
Submission class code description
Efficacy
Application docs
1. ID
  84007
  Url
  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig2s000ltr.pdf
  Date
  20251031
  Type
  Letter
2. ID
  84010
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000lbl.pdf#page=33
  Date
  20251031
  Type
  Label
3. ID
  84054
  Url
  https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761404Orig2s000TOC.html
  Date
  20251104
  Type
  Review

Products

Product number
002
Reference drug
No
Brand name
OSENVELT
Reference standard
No
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Active ingredients
1. Name
  DENOSUMAB-BMWO
  Strength
  120MG/1.7ML(70MG/ML)
Product number
001
Reference drug
No
Brand name
STOBOCLO
Reference standard
No
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Active ingredients
1. Name
  DENOSUMAB-BMWO
  Strength
  60MG/ML

Harmonized identifiers (openFDA)

Application number: BLA761404
Brand name: STOBOCLO, DENOSUMAB-BMWO, OSENVELT
Generic name: DENOSUMAB-BMWO
Manufacturer name: CELLTRION USA, Inc.
Product NDC: 72606-037, 72606-059, 72606-058, 72606-038
Product type: HUMAN PRESCRIPTION DRUG
Route: SUBCUTANEOUS
Substance name: DENOSUMAB
RxCUI: 2717855, 2717862, 2717866, 2717873
SPL ID: a1cd4ff2-cdab-41fa-b8f5-e2bc0faea49f, 515e94c3-ab8d-4c35-8e7c-7083fd423d60, 180d317f-8fa9-4e03-bc3e-756bcfbb4fd6, ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
SPL set ID: 10b9eea3-bf70-4ff3-a0b9-54248cbfd156, d378622d-3a13-4918-ae18-3375cd10d270, 7a449553-105c-46a1-bb72-849d8f5b81bd, c5a5d750-80be-49cd-b4a6-c8a815956059
Package NDC: 72606-037-01, 72606-059-01, 72606-058-01, 72606-038-01
Nui: N0000187055, N0000187054
Pharm class epc: RANK Ligand Inhibitor [EPC]
Pharm class moa: RANK Ligand Blocking Activity [MoA]
UNII: 4EQZ6YO2HI

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.