Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018983
Company: MYLAN SPECIALITY LP
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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | No | No |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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | No | No |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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | No | No |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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | No | No |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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | No | No |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 | Discontinued | None | 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018983s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018983Orig1s051ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018983s051lbl.pdf | |
| 08/19/2013 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf |