Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202348
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
07/15/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.

10/31/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/04/2015 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

MORPHINE SULFATE

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 205509 ANI PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 208809 HI TECH
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 201011 NOSTRUM LABS INC
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

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