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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008381
Company: ANI PHARMS

Products on NDA 008381

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE PLAIN	PROMETHAZINE HYDROCHLORIDE	25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP;ORAL	Discontinued	None	Yes	No
PROMETHAZINE HYDROCHLORIDE PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008381

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/1952	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2008	SUPPL-30	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf
04/02/2008	SUPPL-28	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf
06/27/2003	SUPPL-27	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
06/27/2003	SUPPL-26		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
05/06/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/30/1992	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/06/1992	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
12/12/1989	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/13/1989	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/1988	SUPPL-18	Labeling		Label is not available on this site.
03/02/1987	SUPPL-14	Labeling		Label is not available on this site.
09/08/1986	SUPPL-13	Labeling		Label is not available on this site.
11/04/1985	SUPPL-12	Labeling		Label is not available on this site.
07/27/1985	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/29/1986	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
04/18/1984	SUPPL-9	Efficacy-New Indication		Label is not available on this site.
04/18/1984	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/18/1984	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 008381

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2008	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf
04/02/2008	SUPPL-28	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf

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