Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040432
Company: ANDA REPOSITORY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG 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
01/22/2003 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
10/28/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-12 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.

08/15/2018 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/23/2016 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf
06/27/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/10/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/18/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;7.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANEXSIA 7.5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040405 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 209037 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040746 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040432 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 211487 ASCENT PHARMS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 201013 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 203863 EPIC PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 206245 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202935 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202991 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 090118 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040656 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 210211 WES PHARMA INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040148 APIL

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