Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210347
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
PIROXICAM | PIROXICAM | 20MG | 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 |
---|---|---|---|---|---|---|---|
01/26/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/03/2023 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/16/2022 | SUPPL-4 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/16/2022 | SUPPL-3 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/23/2019 | SUPPL-2 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
PIROXICAM
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELDENE | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 018147 | PFIZER |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 206152 | MICRO LABS |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 074118 | NOSTRUM LABS INC |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 206136 | STRIDES PHARMA |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210347 | STRIDES PHARMA |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 074131 | TEVA |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 208340 | UNICHEM |
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 205585 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELDENE | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 018147 | PFIZER |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206152 | MICRO LABS |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074118 | NOSTRUM LABS INC |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206136 | STRIDES PHARMA |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210347 | STRIDES PHARMA |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074131 | TEVA |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 208340 | UNICHEM |
PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 205585 | ZYDUS LIFESCIENCES |