← FDA DRUG APPROVALS

FDA ANDA · ANDA077273

TUSSICAPS

Sponsor: ECR PHARMA

APPLICATION
ANDA077273
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-24
LATEST ACTION
2014-11-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TUSSICAPSDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 8MG MALEATE, HYDROCODONE POLISTIREX EQ 10MG BITARTRATE · CAPSULE, EXTENDED RELEASE · ORAL
TUSSICAPSDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 4MG MALEATE, HYDROCODONE POLISTIREX EQ 5MG BITARTRATE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2014-11-20Labeling · Supplement 8 · standardAP
2009-03-03Labeling · Supplement 2AP
2007-09-24Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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