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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015230
Company: HIKMA

Products on NDA 015230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMICAR	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 015230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/1964	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2009	SUPPL-37	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf
08/19/2008	SUPPL-35	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf
08/24/2004	SUPPL-31	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf
09/02/2003	SUPPL-30	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/02/2003	SUPPL-29	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/02/2003	SUPPL-28	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/14/1999	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
09/14/1999	SUPPL-26	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/14/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
01/17/1997	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
04/16/1997	SUPPL-23	Labeling		Label is not available on this site.
11/04/1986	SUPPL-22	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/17/1986	SUPPL-21	Labeling		Label is not available on this site.
06/06/1983	SUPPL-20	Labeling		Label is not available on this site.
12/10/1982	SUPPL-19	Labeling		Label is not available on this site.
09/22/1982	SUPPL-18	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/03/1990	SUPPL-17	Labeling		Label is not available on this site.
12/22/1980	SUPPL-15	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/17/1978	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 015230

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2009	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf
08/19/2008	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf

Therapeutic Equivalents for NDA 015230

AMICAR

SOLUTION;ORAL; 0.25GM/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMICAR	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	Yes	AA	015230	HIKMA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	213825	AJENAT PHARMS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	212780	AMNEAL
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	216464	ANNORA PHARMA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	216804	AUROBINDO PHARMA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	214140	CARNEGIE
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	215100	MSN
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	215510	REGCON HOLDINGS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	213216	SCIEGEN PHARMS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	213213	SUNNY
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	212494	TP ANDA HOLDINGS

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