Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075907
Company: PRINSTON INC

Products on ANDA 075907

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075907

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075907.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/07/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075907

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	078164	AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	079237	IPCA LABS LTD
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	078391	JUBILANT CADISTA
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	075907	PRINSTON INC
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	203561	SCIEGEN PHARMS INC
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	No	AB	090510	UNICHEM
MICROZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	Yes	AB	020504	TEVA BRANDED PHARM