Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207709
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription AA No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription AA No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;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
09/13/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-2 Labeling-Medication Guide, 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.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

TABLET;ORAL; 300MG;5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 209036 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 206470 ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 206869 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 207709 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 040658 MIKART
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 206142 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 205001 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 207808 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 206718 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 090415 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Prescription No AA 207509 WES PHARMA INC

TABLET;ORAL; 300MG;7.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 209036 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 206470 ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 207709 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 040658 MIKART
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 206142 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 205001 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 207808 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 206718 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 090415 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Prescription No AA 207509 WES PHARMA INC

TABLET;ORAL; 300MG;10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 209036 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 206470 ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 207137 AMNEAL PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 207709 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 040658 MIKART
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 206142 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 205001 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 207808 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 206718 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 090415 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;ORAL Prescription No AA 207509 WES PHARMA INC

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