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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216232
Company: MICRO LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription AB1 No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription AB1 No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE 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
03/29/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075049 APNAR PHARMA LP
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 206993 CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 201336 HERITAGE PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075464 LANDELA PHARM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 216232 MICRO LABS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075452 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 076001 TEVA PHARMS USA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription Yes AB1 018936 ELI LILLY AND CO

CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075049 APNAR PHARMA LP
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 206993 CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 201336 HERITAGE PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075464 LANDELA PHARM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 216232 MICRO LABS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075452 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 076001 TEVA PHARMS USA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription Yes AB1 018936 ELI LILLY AND CO

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 090223 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075049 APNAR PHARMA LP
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 078619 AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 206993 CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 201336 HERITAGE PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075245 IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075465 MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 216232 MICRO LABS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 076990 SUN PHARM INDS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 075452 TEVA
PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription Yes AB 018936 ELI LILLY AND CO
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