Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209897
Company: HIBROW HLTHCARE
Company: HIBROW HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 09/06/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209897Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/06/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
OXYCODONE HYDROCHLORIDE
SOLUTION;ORAL; 100MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 208593 | ABHAI LLC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211749 | ALKEM LABS LTD |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 209021 | ASCENT PHARMS INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 200535 | GENUS LIFESCIENCES |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 209897 | HIBROW HLTHCARE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213761 | QUAGEN |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 210758 | SPECGX LLC |