Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075030
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEMOLINE | PEMOLINE | 37.5MG | TABLET;ORAL | Discontinued | None | No | No |
| PEMOLINE | PEMOLINE | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| PEMOLINE | PEMOLINE | 18.75MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/29/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75030ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 02/22/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/22/2000 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/22/2000 | SUPPL-8 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 08/13/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 06/11/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |