Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074051
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/31/1993 | 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 |
|---|---|---|---|---|---|
| 09/24/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/27/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/26/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/22/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |