Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091528
Company: NOVEL LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;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
04/20/2011 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
06/28/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
01/13/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

TABLET;ORAL; 1.5MG;5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET;ORAL Prescription No AA 207176 AVANTHI INC
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET;ORAL Prescription No AA 091528 NOVEL LABS INC
TUSSIGON HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET;ORAL Prescription No AA 088508 KING PHARMS

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