Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019279
Company: ROBINS AH
Company: ROBINS AH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIMETANE-DX | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/24/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/22/2001 | SUPPL-10 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/019279s010lbl.pdf | |
05/06/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/03/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/26/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/06/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/22/2001 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/019279s010lbl.pdf |