FDA Approval for NEOSTIGMINE METHYLSULFATE issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 209933
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/25/2017 | ORIG-1 | Approval | 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 |
|---|---|---|---|---|---|
| 05/19/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS; 5MG/10ML (0.5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204078 | EXELA PHARMA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210051 | AMNEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209933 | AMPHASTAR PHARMS INC |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210989 | AMRING PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212512 | BE PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213074 | CAPLIN |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209135 | DR REDDYS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207042 | EUROHLTH INTL SARL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212968 | GLAND PHARMA LTD |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210652 | INDOCO |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212804 | MEITHEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208405 | PAR STERILE PRODUCTS |
SOLUTION;INTRAVENOUS; 10MG/10ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204078 | EXELA PHARMA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210051 | AMNEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209933 | AMPHASTAR PHARMS INC |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210989 | AMRING PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212512 | BE PHARMS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213074 | CAPLIN |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209135 | DR REDDYS |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207042 | EUROHLTH INTL SARL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212968 | GLAND PHARMA LTD |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210652 | INDOCO |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212804 | MEITHEAL |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208405 | PAR STERILE PRODUCTS |