Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009509
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARAMINE | METARAMINOL BITARTRATE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/29/1954 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/2001 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/009509s026lbl.pdf | |
| 02/19/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/09/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/22/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 08/27/1985 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/11/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/22/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/22/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/14/1981 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/03/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2001 | SUPPL-26 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/009509s026lbl.pdf |