Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212280
Company: CIPLA
Company: CIPLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Discontinued | None | No | No |
PREGABALIN | PREGABALIN | 300MG | 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 |
---|---|---|---|---|---|---|---|
01/10/2020 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
07/31/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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06/09/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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06/09/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |