Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091313
Company: MAYNE PHARMA INC
Company: MAYNE PHARMA INC
| 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 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/18/2011 | ORIG-1 | Approval |
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-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 06/01/2017 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-1 | Labeling-Package Insert |
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 | 076636 | ACTAVIS ELIZABETH |
| 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 | 091313 | MAYNE PHARMA INC |
| 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 | 090659 | SUN PHARM INDS INC |
| 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 | 076636 | ACTAVIS ELIZABETH |
| 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 | 091313 | MAYNE PHARMA INC |
| 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 | 090659 | SUN PHARM INDS INC |
| 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 | 076636 | ACTAVIS ELIZABETH |
| 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 | 091313 | MAYNE PHARMA INC |
| 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 | 090659 | SUN PHARM INDS INC |
| ROXICODONE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 021011 | SPECGX LLC |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 203638 | AMNEAL PHARMS |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091393 | AVANTHI INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202662 | EPIC PHARMA LLC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091313 | MAYNE PHARMA INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204021 | NOVEL LABS INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207119 | NUVO PHARM |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091490 | RHODES PHARMS |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090659 | SUN PHARM INDS INC |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 203638 | AMNEAL PHARMS |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091393 | AVANTHI INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 202662 | EPIC PHARMA LLC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091313 | MAYNE PHARMA INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 204021 | NOVEL LABS INC |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207119 | NUVO PHARM |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091490 | RHODES PHARMS |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 090659 | SUN PHARM INDS INC |
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