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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207326
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION 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
08/23/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

PACLITAXEL

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 205720 ACCORD HLTHCARE
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 090130 ACTAVIS TOTOWA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 216874 ALEMBIC PHARMS LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 077574 FRESENIUS KABI USA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 207326 GLAND PHARMA LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075190 HIKMA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 076131 HOSPIRA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 213434 MSN
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075184 TEVA PHARMS
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