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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019781
Company: ACERTIS PHARMS

Products on NDA 019781

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019781

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2026	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019781s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019781Orig1s026ltr.pdf
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.

Labels for NDA 019781

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-Patient 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
02/15/2024	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

Therapeutic Equivalents for NDA 019781

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	ACERTIS PHARMS

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	ACERTIS PHARMS

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