Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019011
Company: BRAINTREE
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 | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/13/1984 | 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019011Orig1s033ltr.pdf | |
| 06/05/2020 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019011Orig1s031ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf | |
| 05/14/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf | |
| 06/05/2020 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011Orig1s031lbl.pdf | |
| 06/05/2020 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011Orig1s031lbl.pdf | |
| 06/05/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011Orig1s031lbl.pdf | |
| 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 |