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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207880
Company: HERITAGE PHARMA
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
05/26/2017 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 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 213095 AUROBINDO PHARMA
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 208357 NOVAST LABS

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 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 213095 AUROBINDO PHARMA
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 208357 NOVAST LABS
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