Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENERGAN VC | PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
09/14/1954 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
02/23/2001 | SUPPL-26 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008604_S026_PHENERGRAN_VC_AP.pdf |
05/06/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1988 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/11/1988 | SUPPL-16 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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09/14/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
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07/30/1985 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/29/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/11/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/02/1984 | SUPPL-11 | Efficacy |
Label is not available on this site. |
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04/02/1984 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |