Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077857
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM 100MG/ML (100MG/ML) INJECTABLE;SUBCUTANEOUS Prescription AP No No
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 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
07/23/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077857s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/077857Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2020 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/28/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

10/29/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/31/2011 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

07/25/2011 SUPPL-5 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

11/22/2011 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

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 078990 APOTEX INC
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 076726 ZYDUS PHARMS
LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM 100MG/ML (100MG/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 020164 SANOFI AVENTIS US

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 078990 APOTEX INC
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 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 078990 APOTEX INC
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 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 078990 APOTEX INC
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 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 078990 APOTEX INC
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 076726 ZYDUS PHARMS
LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM 80MG/0.8ML (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 078990 APOTEX INC
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 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 078990 APOTEX INC
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 076726 ZYDUS PHARMS
LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM 150MG/ML (150MG/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 020164 SANOFI AVENTIS US

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