Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020645
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMMONUL | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/17/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020645ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020645s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020645Orig1s012ltr.pdf | |
01/10/2017 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/07/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/2011 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020645s008ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/22/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020645s012lbl.pdf | |
06/30/2011 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf | |
02/17/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf |
AMMONUL
SOLUTION;INTRAVENOUS; 10%;10% (5GM/50ML;5GM/50ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMMONUL | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020645 | BAUSCH |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207096 | AILEX PHARMS LLC |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208521 | MAIA PHARMS INC |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205880 | NAVINTA LLC |