Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204695
Company: SAGENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription AP 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
08/22/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204695Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION; 0.004MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription Yes AP 018938 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 091374 AM REGENT
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204695 SAGENT PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204751 SAGENT PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 091280 SUN PHARM INDS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 074888 TEVA PHARMS USA

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