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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202800
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription AA No No
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription AA No No
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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
04/15/2013 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
10/31/2024 SUPPL-18 REMS - MODIFIED - D-N-A

Label is not available on this site.

03/06/2024 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/05/2024 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/05/2024 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/05/2024 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/07/2019 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/20/2018 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/29/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;15MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 089990 STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 211610 WES PHARMA INC

TABLET;ORAL; 300MG;30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040779 AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 089805 STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 211610 WES PHARMA INC

TABLET;ORAL; 300MG;60MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 089828 STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 087083 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 211610 WES PHARMA INC
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