Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
LORAZEPAM | LORAZEPAM | 4MG/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 |
---|---|---|---|---|---|---|---|
04/12/1994 | 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 |
---|---|---|---|---|---|
09/25/2023 | SUPPL-45 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/29/2022 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
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06/09/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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06/09/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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05/13/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/05/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/14/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/21/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
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04/21/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1995 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
LORAZEPAM
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018140 | HIKMA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074243 | HOSPIRA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074282 | HOSPIRA |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076150 | INTL MEDICATION SYS |
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075025 | RISING |
INJECTABLE;INJECTION; 4MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATIVAN | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018140 | HIKMA |
LORAZEPAM | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074243 | HOSPIRA |
LORAZEPAM | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074282 | HOSPIRA |