Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062475
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXY 100 | DOXYCYCLINE HYCLATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| DOXY 200 | DOXYCYCLINE HYCLATE | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/28/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062475s038lbl.pdf |