Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019882
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNESCAN MAG3 | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
---|---|---|---|---|---|---|---|
06/15/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/28/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/16/2001 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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04/08/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/11/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/27/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/26/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/27/1992 | SUPPL-1 | Efficacy-New Patient Population |
Label is not available on this site. |
TECHNESCAN MAG3
INJECTABLE;INJECTION; N/A
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TECHNESCAN MAG3 | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | Yes | AP | 019882 | CURIUM |
TECHNETIUM TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 206489 | MEDI-RADIOPHARMA |
TECHNETIUM TC99M MERTIATIDE KIT | TECHNETIUM TC-99M MERTIATIDE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 208994 | SUN PHARM INDS INC |