Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084094
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/15/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/28/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/03/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/15/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/19/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/20/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/05/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |