Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211454
Company: WINDER LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription AA No No
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription AA No No
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/12/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

MORPHINE SULFATE

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 211454 WINDER LABS LLC

SOLUTION;ORAL; 20MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 206420 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 203519 TRIS PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 211454 WINDER LABS LLC

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 208809 AKORN
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 201574 PADDOCK LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206573 PHARM ASSOC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 202348 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 211454 WINDER LABS LLC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English