Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075324
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
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 |
---|---|---|---|---|---|---|---|
06/20/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75324ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75324ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
04/27/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/11/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
MIDAZOLAM HYDROCHLORIDE
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 |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075494 | EPIC PHARMA LLC |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075154 | FRESENIUS KABI USA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090696 | GLAND PHARMA LTD |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075243 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075247 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075324 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075421 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212847 | HIKMA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075293 | HOSPIRA |
MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217504 | MICRO LABS |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203460 | FRESENIUS KABI USA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075857 | HOSPIRA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090315 | STERISCIENCE SPECLTS |
MIDOZALAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090316 | STERISCIENCE SPECLTS |
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 SPECLTS |
MIDOZALAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090316 | STERISCIENCE SPECLTS |