Drugs@FDA: FDA-Approved Drugs
Company: VIRTUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETRIUM | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
PROMETRIUM | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
PROMETRIUM | PROGESTERONE | 300MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/14/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19781ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19781.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019781s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019781Orig1s025ltr.pdf | |
11/18/2020 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019781Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019781Orig1s022ltr.pdf | |
09/30/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/19/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/01/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf | |
06/30/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf | |
03/04/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf |
03/01/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/10/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/10/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/17/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/15/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019781s025lbl.pdf | |
11/18/2020 | SUPPL-22 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019781Orig1s022lbl.pdf | |
11/01/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf | |
06/30/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf | |
05/14/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19781lbl.pdf |
PROMETRIUM
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207724 | AMNEAL PHARMS NY |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 200900 | BIONPHARMA |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208801 | DR REDDYS |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211285 | EUGIA PHARMA |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 200456 | SOFGEN PHARMS |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205229 | XIROMED |
PROMETRIUM | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 019781 | VIRTUS |
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207724 | AMNEAL PHARMS NY |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 200900 | BIONPHARMA |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 208801 | DR REDDYS |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211285 | EUGIA PHARMA |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 200456 | SOFGEN PHARMS |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 205229 | XIROMED |
PROMETRIUM | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 019781 | VIRTUS |