Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076330
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
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 | Yes |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/08/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/16/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2022 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/27/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/12/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/03/2009 | SUPPL-4 | Labeling |
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 |
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 |
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 |