Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 079017
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/25/2015 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ATOMOXETINE HYDROCHLORIDE
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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090609 | DR REDDYS LABS LTD |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 079019 | GLENMARK PHARMS LTD |
| 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 |
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