Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETRAFON 2-10 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
ETRAFON 2-25 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
ETRAFON-A | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
ETRAFON-FORTE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
09/17/1969 | 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 |
---|---|---|---|---|---|
05/10/2002 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf |
05/10/2002 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf |
03/02/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/18/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/03/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/10/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/23/2000 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/21/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/23/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
08/23/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
08/03/1988 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/15/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/17/1981 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/14/1980 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/29/1980 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/06/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |