Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208600
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/14/2019 | 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 |
---|---|---|---|---|---|
11/15/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ENOXAPARIN SODIUM
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 300MG/3ML (100MG/ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 208600 | AMPHASTAR PHARMS INC |
ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 214856 | NANJING KING-FRIEND |
ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 078660 | SANDOZ INC |
LOVENOX | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AB | 020164 | SANOFI AVENTIS US |