Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019011
Company: BRAINTREE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GOLYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION;ORAL Prescription AA Yes Yes
GOLYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET FOR SOLUTION;ORAL Prescription None 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
07/13/1984 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
05/06/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/05/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/23/2013 SUPPL-25 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019011s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019011Orig1s025ltr.pdf
09/19/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19011slr015ltr.pdf
02/23/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/07/1999 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/25/1999 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/03/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/30/1995 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1993 SUPPL-8 Labeling

Label is not available on this site.

03/24/1993 SUPPL-7 Labeling

Label is not available on this site.

09/17/1992 SUPPL-6 Labeling

Label is not available on this site.

08/20/1992 SUPPL-5 Labeling

Label is not available on this site.

06/02/1992 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1986 SUPPL-3 Labeling

Label is not available on this site.

04/19/1985 SUPPL-2 Labeling

Label is not available on this site.

02/22/1985 SUPPL-1 Labeling

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-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019011s025lbl.pdf

GOLYTELY

FOR SOLUTION;ORAL; 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GOLYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION;ORAL Prescription Yes AA 019011 BRAINTREE
PEG 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION;ORAL Prescription No AA 090231 NOVEL LABS INC
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION;ORAL Prescription No AA 204558 STRIDES PHARMA

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