Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080832
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/03/1972 | 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 |
|---|---|---|---|---|---|
| 04/07/1997 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1995 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1990 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
| 05/21/1990 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 10/18/1989 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 02/02/1987 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1987 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1985 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1985 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1985 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1984 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1983 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1983 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1983 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1982 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |