Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206136
Company: BRECKENRIDGE
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
06/20/2017 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
07/23/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-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 206136 BRECKENRIDGE
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 205585 CADILA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 209256 HIKMA PHARMS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 206152 MICRO LABS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 074116 MYLAN IRELAND LTD
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 LABS LTD

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 206136 BRECKENRIDGE
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 205585 CADILA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 209256 HIKMA PHARMS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 206152 MICRO LABS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 074118 MYLAN IRELAND LTD
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 LABS LTD

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