Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS UT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROGESTERONE | PROGESTERONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/11/1978 | 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 |
|---|---|---|---|---|---|
| 08/21/2018 | SUPPL-111 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017362s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017362Orig1s111ltr.pdf | |
| 01/09/2007 | SUPPL-104 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017362s104_ltr.pdf | |
| 08/12/2002 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/2001 | SUPPL-95 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1999 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1998 | SUPPL-90 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 02/19/1998 | SUPPL-88 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/22/1997 | SUPPL-86 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 12/03/1991 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 04/08/1991 | SUPPL-81 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 12/15/1980 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 08/26/1980 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 07/18/1980 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 06/11/1980 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 04/15/1980 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 03/28/1980 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 02/12/1980 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 02/06/1980 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 02/06/1980 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 12/12/1979 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 12/14/1979 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 12/10/1979 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 12/14/1979 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 08/23/1979 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 08/23/1979 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 08/15/1979 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 12/26/1978 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 12/26/1978 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 12/12/1978 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/21/2018 | SUPPL-111 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017362s111lbl.pdf | |
| 01/09/2007 | SUPPL-104 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017362s104lbl.pdf |