Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078983
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/078983Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/19/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 18MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078983 | APOTEX |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079021 | STRIDES PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |