Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
05/14/2021 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019797Orig1s029ltr.pdf | |
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 |
---|---|---|---|---|---|
05/14/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf | |
05/14/2021 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019797s029lbl.pdf | |
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 |
---|---|---|---|---|---|---|---|---|
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 | 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 |
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 |
---|---|---|---|---|---|---|---|---|
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 | 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 |