Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088508
Company: KING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TUSSIGON HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/1985 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-21 Labeling-Medication Guide

Label is not available on this site.

06/28/2018 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/28/2018 SUPPL-19 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

11/22/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/15/1993 SUPPL-7 Labeling

Label is not available on this site.

12/15/1992 SUPPL-6 Labeling

Label is not available on this site.

01/23/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/06/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/06/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/06/1989 SUPPL-2 Labeling

Label is not available on this site.

03/31/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TUSSIGON

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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