Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005845
Company: MCNEIL CONS
Company: MCNEIL CONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 12.5MG/5ML | ELIXIR;ORAL | Discontinued | None | No | No |
| BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 03/04/1946 | 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 |
|---|---|---|---|---|---|
| 01/14/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1986 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 05/19/1986 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 08/02/1985 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 08/02/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 08/07/1985 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 05/19/1986 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/30/1984 | SUPPL-31 | Efficacy |
Label is not available on this site. |