Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205177
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/31/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205177Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-4 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 205177 | ANI PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 202773 | AVANTHI INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 200534 | GENUS LIFESCIENCES |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 204752 | NOVEL LABS INC |