Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202116
Company: ALVOGEN
Company: ALVOGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | AB | No | No |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/30/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-5 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
OXYCODONE HYDROCHLORIDE
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 202116 | ALVOGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203638 | AMNEAL PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202160 | AUROLIFE PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091393 | AVANTHI INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090895 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202662 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204021 | NOVEL LABS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207119 | NUVO PHARM |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091490 | RHODES PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077712 | STRIDES PHARMA |
ROXICODONE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021011 | SPECGX LLC |
TABLET;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202116 | ALVOGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 203638 | AMNEAL PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 207418 | ASCENT PHARMS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202160 | AUROLIFE PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 091393 | AVANTHI INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 090895 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202662 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 204021 | NOVEL LABS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 207119 | NUVO PHARM |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 091490 | RHODES PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 076758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 077712 | STRIDES PHARMA |
ROXICODONE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 021011 | SPECGX LLC |
TABLET;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202116 | ALVOGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 203638 | AMNEAL PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 207418 | ASCENT PHARMS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202160 | AUROLIFE PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 091393 | AVANTHI INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 090895 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202662 | EPIC PHARMA LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 204021 | NOVEL LABS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 207119 | NUVO PHARM |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 091490 | RHODES PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 076758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 077712 | STRIDES PHARMA |
ROXICODONE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 021011 | SPECGX LLC |