Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018983
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLYTE 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 Discontinued None No No
COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET FOR SOLUTION;ORAL Discontinued None No No
COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET FOR SOLUTION;ORAL Discontinued None No No
COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT FOR SOLUTION;ORAL Discontinued None No No
COLYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT FOR SOLUTION;ORAL Discontinued None No No
COLYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT FOR SOLUTION;ORAL Prescription AA No No
COLYTE-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT FOR SOLUTION;ORAL Discontinued None No No
COLYTE-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT FOR SOLUTION;ORAL Discontinued None 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
10/26/1984 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
08/19/2013 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018983Orig1s047ltr.pdf
04/24/2013 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/23/2003 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18983slr037ltr.pdf
11/12/2002 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/16/2002 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18983slr035ltr.pdf
05/16/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/12/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/20/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/16/2000 SUPPL-31 Labeling

Label is not available on this site.

10/16/2000 SUPPL-30 Labeling

Label is not available on this site.

11/30/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1998 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/21/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/06/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/24/1996 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/13/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/04/1994 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/06/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/25/1994 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/25/1994 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/05/1993 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1990 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/14/1991 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/31/1989 SUPPL-8 Labeling

Label is not available on this site.

01/31/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/27/1986 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/19/1986 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
08/19/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf

COLYTE

There are no Therapeutic Equivalents.

COLYTE WITH FLAVOR PACKS

FOR SOLUTION;ORAL; 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLYTE WITH FLAVOR PACKS POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT FOR SOLUTION;ORAL Prescription No AA 018983 MYLAN SPECIALITY LP
PEG 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT FOR SOLUTION;ORAL Prescription No AA 090186 NOVEL LABS INC

COLYTE-FLAVORED

There are no Therapeutic Equivalents.

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