Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078271
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL 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
12/23/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2019 SUPPL-17 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

SPRAY, METERED;NASAL; 0.01MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 017922 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 074830 BAUSCH AND LOMB
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076703 APOTEX INC
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 078271 SUN PHARM
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091345 ZYDUS PHARMS
MINIRIN DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 021333 FERRING

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