Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019971
Company: DHL
Company: DHL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/28/1995 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019971ap.pdf |