Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078163
Company: ORCHID HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription AB 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
07/02/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078163s000_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/24/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/12/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/12/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/13/2011 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/14/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

TERBINAFINE HYDROCHLORIDE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMISIL TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription Yes AB 020539 NOVARTIS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078297 AUROBINDO PHARMA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077714 BRECKENRIDGE PHARM
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077137 CIPLA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076390 DR REDDYS LABS INC
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078157 GLENMARK GENERICS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077919 HARRIS PHARM
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076377 HERITAGE PHARMA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077533 INVAGEN PHARMS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078163 ORCHID HLTHCARE

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