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Abbreviated New Drug Application (ANDA): 074415
Company: NOSTRUM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUCRALFATE SUCRALFATE 1GM 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
06/08/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74415ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74415ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

01/16/2008 SUPPL-8 Labeling

Label is not available on this site.

09/19/2007 SUPPL-6 Labeling

Label is not available on this site.

02/02/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

SUCRALFATE

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARAFATE SUCRALFATE 1GM TABLET;ORAL Prescription Yes AB 018333 ALLERGAN
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription No AB 215576 AMNEAL PHARMS
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription No AB 074415 NOSTRUM LABS INC
SUCRALFATE SUCRALFATE 1GM TABLET;ORAL Prescription No AB 070848 TEVA
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