Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216953
Company: APTAPHARMA INC
Company: APTAPHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
11/15/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
FLUOXETINE HYDROCHLORIDE
SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 216953 | APTAPHARMA INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 079209 | AUROBINDO PHARMA |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 077849 | LANNETT CO INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075292 | NOSTRUM LABS INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 216448 | NOVITIUM PHARMA |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 076015 | PHARM ASSOC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075506 | TEVA |