Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090850
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 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 |
---|---|---|---|---|---|---|---|
01/25/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090850Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/17/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/27/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/27/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/28/2012 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/21/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075494 | EPIC PHARMA LLC |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075154 | FRESENIUS KABI USA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090850 | GLAND PHARMA LTD |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075243 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075247 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075324 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075421 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212847 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075293 | HOSPIRA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217504 | MICRO LABS |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203460 | FRESENIUS KABI USA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075857 | HOSPIRA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090315 | STERISCIENCE |
MIDOZALAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090316 | STERISCIENCE |