Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212458
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYANOCOBALAMIN | CYANOCOBALAMIN | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/09/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212458Orig1s000ltr.pdf |
CYANOCOBALAMIN
SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYANOCOBALAMIN | CYANOCOBALAMIN | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 210629 | LUPIN |
CYANOCOBALAMIN | CYANOCOBALAMIN | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 212458 | PADAGIS ISRAEL |