Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040355
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;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
05/31/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40355ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-35 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/22/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/08/2003 SUPPL-4 Labeling

Label is not available on this site.

11/18/2002 SUPPL-2 Labeling

Label is not available on this site.

06/06/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;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 325MG;10MG TABLET;ORAL Prescription No AA 209037 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040746 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 211487 ASCENT PHARMS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 201013 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 203863 EPIC PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 206245 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202935 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202991 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040400 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 090118 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040355 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 210211 WES PHARMA INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040148 APIL

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