Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202729
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| 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 |
|---|---|---|---|---|---|---|---|
| 08/27/2020 | ORIG-1 | Approval |
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 | 202729 | ACCORD HLTHCARE |
| 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 | 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 | 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 | 202729 | ACCORD HLTHCARE |
| 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 | 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 | 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 | 202729 | ACCORD HLTHCARE |
| 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 | 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 | 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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