Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009486
Company: MCNEIL CONS
Company: MCNEIL CONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENADRYL PRESERVATIVE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/30/1957 | 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 |
|---|---|---|---|---|---|
| 10/24/2003 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09486slr028ltr.pdf |
| 12/14/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/01/1997 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/06/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/18/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 03/31/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/04/1997 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/13/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 08/20/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/16/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/16/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |