Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207338
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL CITRATE EQ 0.1MG BASE TABLET;SUBLINGUAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription AB No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL 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
11/17/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207338Orig1s000ltr.pdf

FENTANYL CITRATE

TABLET;SUBLINGUAL; EQ 0.1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.1MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.1MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English