Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217193
Company: INVAGEN PHARMS
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 |