Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088235
Company: CMP PHARMA INC

Products on ANDA 088235

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	50MG/5ML	SYRUP;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/1983	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
02/05/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/29/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/09/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
09/14/1999	SUPPL-5	Labeling		Label is not available on this site.
12/14/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/20/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/29/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088235

ISONIAZID

SYRUP;ORAL; 50MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISONIAZID	ISONIAZID	50MG/5ML	SYRUP;ORAL	Prescription	No	AA	081118	CHARTWELL RX
ISONIAZID	ISONIAZID	50MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	088235	CMP PHARMA INC