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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217193
Company: INVAGEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION;SUBCUTANEOUS Prescription AB No No
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION;SUBCUTANEOUS Prescription AB No No
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION;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
05/21/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217193Orig1s000ltr.pdf

LANREOTIDE ACETATE

SOLUTION;SUBCUTANEOUS; EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION;SUBCUTANEOUS Prescription No AB 217193 INVAGEN PHARMS
SOMATULINE DEPOT LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION;SUBCUTANEOUS Prescription Yes AB 022074 IPSEN PHARMA

SOLUTION;SUBCUTANEOUS; EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION;SUBCUTANEOUS Prescription No AB 217193 INVAGEN PHARMS
SOMATULINE DEPOT LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION;SUBCUTANEOUS Prescription Yes AB 022074 IPSEN PHARMA

SOLUTION;SUBCUTANEOUS; EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANREOTIDE ACETATE LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION;SUBCUTANEOUS Prescription No AB 217193 INVAGEN PHARMS
SOMATULINE DEPOT LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION;SUBCUTANEOUS Prescription Yes AB 022074 IPSEN PHARMA
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