Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074888
Company: MEITHEAL

Products on ANDA 074888

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074888

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/1997	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
08/28/2024	SUPPL-30	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/25/2019	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
07/25/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/27/2009	SUPPL-9	Labeling		Label is not available on this site.
03/25/2002	SUPPL-2	Labeling		Label is not available on this site.
08/10/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074888

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	NORDIC PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	219981	CAPLIN
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
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	210218	UBI
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210223	UBI