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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210223
Company: UBI
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
09/17/2020 ORIG-1 Approval STANDARD

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 215961 DR REDDYS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 216904 GLAND
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 216922 GLAND PHARMA LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 074888 MEITHEAL
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 210218 UBI
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 210223 UBI
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