Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 200644
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 11/07/2012 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200644Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
ACETYLCYSTEINE
INJECTABLE;INTRAVENOUS; 6GM/30ML (200MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETADOTE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021539 | CUMBERLAND PHARMS |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203173 | AKORN INC |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207358 | AUROBINDO PHARMA LTD |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 200644 | FRESENIUS KABI USA |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203624 | MYLAN INSTITUTIONAL |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091684 | SAGENT PHARMS |
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