Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081002
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE | MEPERIDINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/30/1993 | 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 |
|---|---|---|---|---|---|
| 01/03/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/03/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/11/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/23/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/02/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/05/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/05/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/29/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/29/1994 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |