Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076684
Company: AMPHASTAR PHARM
Company: AMPHASTAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 09/19/2011 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076684Orig1s000ChemR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/15/2022 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/24/2012 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/24/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
INJECTABLE;SUBCUTANEOUS; 30MG/0.3ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 40MG/0.4ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 60MG/0.6ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 80MG/0.8ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 100MG/ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 120MG/0.8ML (150MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 150MG/ML (150MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |