Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009698
Company: MEDPOINTE PHARM HLC
Company: MEDPOINTE PHARM HLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MILTOWN | MEPROBAMATE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MILTOWN | MEPROBAMATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/28/1955 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 12/13/2001 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 12/13/2001 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 01/18/1994 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/09/1993 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/16/1986 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/01/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/29/1981 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/10/1980 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 04/04/1979 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1978 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/26/1974 | SUPPL-16 | Unspecified |
Label is not available on this site. |
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| 01/15/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |