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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084754
Company: KANCHAN HLTHCARE

Products on ANDA 084754

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084754

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/1976	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
06/05/2024	SUPPL-61	Labeling-Package Insert		Label is not available on this site.
10/02/2000	SUPPL-51	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/27/1995	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
06/02/1995	SUPPL-47	Labeling		Label is not available on this site.
05/25/1994	SUPPL-45	Labeling		Label is not available on this site.
07/20/1992	SUPPL-44	Labeling		Label is not available on this site.
05/31/1991	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
05/02/1991	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
01/04/1990	SUPPL-39	Labeling		Label is not available on this site.
10/28/1991	SUPPL-38	Labeling		Label is not available on this site.
04/05/1990	SUPPL-37	Labeling		Label is not available on this site.
02/08/1989	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
03/28/1989	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
05/13/1988	SUPPL-32	Labeling		Label is not available on this site.
09/01/1982	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
10/08/1982	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084754

DEXAMETHASONE

ELIXIR;ORAL; 0.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	091188	CHARTWELL MOLECULAR
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	084754	KANCHAN HLTHCARE
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	090891	RISING

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