Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210317
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 10MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AB | No | No |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AB | No | No |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/05/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OCTREOTIDE ACETATE
INJECTABLE;INJECTION; EQ 10MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 10MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 10MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |
INJECTABLE;INJECTION; EQ 20MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |
INJECTABLE;INJECTION; EQ 30MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |