Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017362
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription AO Yes Yes
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.

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.

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.

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.

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.

12/10/1979 SUPPL-58 Labeling

Label is not available on this site.

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.

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.

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

PROGESTERONE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription Yes AO 017362 ACTAVIS LABS UT INC
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 210965 EUGIA PHARMA
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 075906 FRESENIUS KABI USA
PROGESTERONE PROGESTERONE 50MG/ML INJECTABLE;INJECTION Prescription No AO 091033 HIKMA FARMACEUTICA

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