Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216807
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/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 |
---|---|---|---|---|---|---|---|
06/13/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OCTREOTIDE ACETATE
INJECTABLE;INJECTION; EQ 0.2MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077450 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216807 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203765 | HERITAGE PHARMS |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075959 | MEITHEAL |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091041 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076330 | WEST-WARD PHARMS INT |
INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077450 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216807 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203765 | HERITAGE PHARMS |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075959 | MEITHEAL |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091041 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076330 | WEST-WARD PHARMS INT |