Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079022
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription AB No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;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
05/30/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/079022Orig1s000ltr.pdf

ATOMOXETINE HYDROCHLORIDE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 18MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

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