Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080727
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1972 | 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 |
|---|---|---|---|---|---|
| 10/29/1999 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1991 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/11/1985 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/11/1985 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |