Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRINALIN | AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE | 1MG;120MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
03/23/1982 | 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 |
---|---|---|---|---|---|
12/12/2002 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr025ltr.pdf |
11/01/2002 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr024ltr.pdf |
11/01/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml |
08/04/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/25/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/13/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml |
05/18/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/01/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/20/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/24/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/06/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/02/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/1984 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/04/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/31/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/24/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/06/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |