Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019781
Company: ACERTIS PHARMS
Company: ACERTIS PHARMS
| 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2026 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019781s026lbl.pdf | |
| 02/12/2026 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019781s026lbl.pdf | |
| 02/12/2026 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019781s026lbl.pdf | |
| 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 |