Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090999
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APREPITANT APREPITANT 40MG CAPSULE;ORAL Prescription AB No No
APREPITANT APREPITANT 80MG CAPSULE;ORAL Prescription AB No No
APREPITANT APREPITANT 125MG 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
09/24/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090999Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/28/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

APREPITANT

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREPITANT APREPITANT 40MG CAPSULE;ORAL Prescription No AB 207777 GLENMARK PHARMS LTD
APREPITANT APREPITANT 40MG CAPSULE;ORAL Prescription No AB 090999 SANDOZ
EMEND APREPITANT 40MG CAPSULE;ORAL Prescription Yes AB 021549 MERCK

CAPSULE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREPITANT APREPITANT 80MG CAPSULE;ORAL Prescription No AB 207777 GLENMARK PHARMS LTD
APREPITANT APREPITANT 80MG CAPSULE;ORAL Prescription No AB 090999 SANDOZ
EMEND APREPITANT 80MG CAPSULE;ORAL Prescription Yes AB 021549 MERCK

CAPSULE;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREPITANT APREPITANT 125MG CAPSULE;ORAL Prescription No AB 207777 GLENMARK PHARMS LTD
APREPITANT APREPITANT 125MG CAPSULE;ORAL Prescription No AB 090999 SANDOZ
EMEND APREPITANT 125MG CAPSULE;ORAL Prescription Yes AB 021549 MERCK

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