Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017486
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM | HEPARIN SODIUM | 40,000 UNITS/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 |
|---|---|---|---|---|---|---|---|
| 12/10/1975 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 03/27/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/25/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/13/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/06/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |