Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078907
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL 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
10/30/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078907s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2017 SUPPL-16 REMS-Modified

Label is not available on this site.

04/24/2017 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/24/2014 SUPPL-12 REMS-Modified

Label is not available on this site.

11/07/2013 SUPPL-11 REMS-Modified

Label is not available on this site.

06/08/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/04/2012 SUPPL-8 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/04/2012 SUPPL-7 REMS-Proposal

Label is not available on this site.

FENTANYL CITRATE

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 0.8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 1.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

TROCHE/LOZENGE;TRANSMUCOSAL; EQ 1.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIQ FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription Yes AB 020747 CEPHALON
FENTANYL CITRATE FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Prescription No AB 078907 SPECGX LLC

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