Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202682
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
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 |
---|---|---|---|---|---|---|---|
03/11/2021 | ORIG-1 | Approval |
Label is not available on this site. |
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 |
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 |