Drugs@FDA: FDA-Approved Drugs
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG 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 |
---|---|---|---|---|---|---|---|
02/10/2011 | 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 |
---|---|---|---|---|---|
02/21/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2023 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/21/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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09/05/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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07/07/2017 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/07/2017 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/23/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/02/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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07/14/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
INJECTABLE;INJECTION; EQ 0.05MG 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 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |
INJECTABLE;INJECTION; EQ 0.1MG 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 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216839 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217860 | SHUANGCHENG |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |
INJECTABLE;INJECTION; EQ 0.5MG 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 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216839 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |