Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075252
Company: AAIPHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZASAN AZATHIOPRINE 50MG TABLET;ORAL Prescription AB No No
AZASAN AZATHIOPRINE 25MG TABLET;ORAL Prescription AB No No
AZASAN AZATHIOPRINE 75MG TABLET;ORAL Prescription AB No No
AZASAN AZATHIOPRINE 100MG TABLET;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
06/07/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75252ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/2015 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/02/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/13/2006 SUPPL-15 Labeling

Label is not available on this site.

03/02/2006 SUPPL-14 Labeling

Label is not available on this site.

02/03/2003 SUPPL-11 Labeling

Label is not available on this site.

02/03/2003 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

02/03/2003 SUPPL-9 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/03/2003 SUPPL-8 Labeling

Label is not available on this site.

02/03/2003 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/2003 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/03/2003 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/14/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2001 SUPPL-3 Labeling

Label is not available on this site.

07/18/2001 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

11/20/2000 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

AZASAN

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 074069 AMNEAL PHARMS LLC
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075568 MYLAN
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA
IMURAN AZATHIOPRINE 50MG TABLET;ORAL Prescription Yes AB 016324 SEBELA IRELAND LTD

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

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