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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076758
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 5MG 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
06/30/2004 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
09/21/2021 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2021 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2021 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2018 SUPPL-17 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/21/2021 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/14/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/29/2008 SUPPL-3 Labeling

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

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 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 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 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

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 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 5MG 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 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 076758 SPECGX LLC
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 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 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
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