Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210371
Company: ABHAI LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription AB No No
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG 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
01/28/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

DESMOPRESSIN ACETATE

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription Yes AB 019955 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 210371 ABHAI LLC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 076470 ACTAVIS LABS FL INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 201831 GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 207880 HERITAGE PHARMA
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 077122 IMPAX LABS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 200653 MYLAN

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription Yes AB 019955 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 210371 ABHAI LLC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 076470 ACTAVIS LABS FL INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 201831 GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 207880 HERITAGE PHARMA
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 077122 IMPAX LABS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 200653 MYLAN

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