Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019797
Company: BRAINTREE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription AA Yes Yes
NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/1991 ORIG-1 Approval Type 4 - New Combination 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
09/23/2013 SUPPL-22 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019797Orig1s022ltr.pdf
01/27/2010 SUPPL-18 Labeling

Label is not available on this site.

08/07/2003 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/30/2003 SUPPL-13 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19797scf013ltr.pdf
02/23/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/09/1999 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/28/2000 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/13/1999 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/25/1999 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/10/1997 SUPPL-7 Labeling

Label is not available on this site.

12/10/1997 SUPPL-6 Labeling

Label is not available on this site.

06/03/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/18/1994 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/29/1993 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/23/2013 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf

NULYTELY

FOR SOLUTION;ORAL; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAX-LYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 079232 PADDOCK LLC
NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription Yes AA 019797 BRAINTREE
NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription Yes AA 019797 BRAINTREE
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 202060 BRECKENRIDGE PHARM
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 090019 NOVEL LABS INC
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 204559 STRIDES PHARMA
TRILYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 076491 MYLAN PHARMS INC

NULYTELY-FLAVORED

FOR SOLUTION;ORAL; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAX-LYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 079232 PADDOCK LLC
NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription Yes AA 019797 BRAINTREE
NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription Yes AA 019797 BRAINTREE
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 202060 BRECKENRIDGE PHARM
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 090019 NOVEL LABS INC
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 204559 STRIDES PHARMA
TRILYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION;ORAL Prescription No AA 076491 MYLAN PHARMS INC

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