Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091684
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
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 |
---|---|---|---|---|---|---|---|
10/31/2017 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/05/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2020 | SUPPL-1 | Labeling-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 | 207358 | EUGIA PHARMA |
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 | 213693 | GLENMARK PHARMS INC |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215620 | INDOCO |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203173 | RISING |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091684 | SAGENT PHARMS INC |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 218397 | SOMERSET THERAPS LLC |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217182 | STERISCIENCE SPECLTS |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208166 | ZYDUS PHARMS |