Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079016
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| 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 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/079016Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/079016Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2022 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2022 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/30/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/079016Orig1s000lbl.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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| 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 |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 079016 | AUROBINDO PHARMA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 202682 | HETERO LABS LTD V |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 079022 | TEVA PHARMS USA |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 079017 | ZYDUS PHARMS USA INC |
| STRATTERA | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021411 | LILLY |