Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040838
Company: PHARM ASSOC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;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
05/10/2013 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
10/11/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-11 REMS - PROPOSAL - D-N-A

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.
12/15/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
10/18/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

SOLUTION;ORAL; 325MG/15ML;7.5MG/15ML
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 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040482 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040894 GENUS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040838 PHARM ASSOC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 200343 VISTAPHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 211023 WES PHARMA INC

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