Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018571
Company: PHARMACARE
Company: PHARMACARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETHINE | TERBUTALINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/30/1981 | 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 |
|---|---|---|---|---|---|
| 04/08/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/19/2003 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr019ltr.pdf |
| 01/25/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1998 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/09/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/19/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/07/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/05/1995 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/09/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/09/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |