Application 218391

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROGESTERONE	PROGESTERONE	INSERT;VAGINAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218391-001	PROGESTERONE	PROGESTERONE	100MG	INSERT / VAGINAL	AB		2025-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A218391-001	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A218391-001	CGT	2026-03-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218391-001	PROGESTERONE	100MG	INSERT / VAGINAL	AB	2025-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218391-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218391-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218391-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218391-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218391-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218391-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	A218391-001	CGT	2026-03-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218391-001	CGT	2026-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218391-001	CGT	2026-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218391-001	CGT	2026-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218391-001	CGT	2026-03-22	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218391-001	CGT	2026-03-22	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Northstar Rx LLC	73229a76-8de3-4cea-886f-568f0b817fea	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Xiromed, LLC	0bf317a8-96d6-849d-7850-9084205a5315	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Proficient Rx LP	199c8575-e113-468f-8eb7-c4930030649c	2026-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	46d97ca6-970f-478f-81ff-1b9a9f6cb2f7	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	eca6a7c0-7f58-4dcf-aec0-9d44fd594aa1	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	NuCare Pharmaceuticals, Inc.	4874ee1b-f661-05f7-e063-6394a90a2b8b	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone 1538	PROGESTERONE	Professional Complementary Health Formulas	a5b8449e-ae6f-48c1-8b71-2dd3c5332cc1	2026-01-08	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Northwind Health Company, LLC	fcebe343-18ac-d4cd-e053-6294a90a72d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Direct_Rx	462ae686-7264-4852-e063-6294a90aae98	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
BUNUSS Phyto-Pro Skin Cream	PROGESTERONE	Jiashen International Trade Limited	44e1ec89-e2ea-d438-e063-6294a90a41f4	2025-12-01	Warnings	Name fallback generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0b3da881-4720-cdee-e063-6394a90aee99	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	41c9546c-a854-4395-9506-d1be61f4e60f	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	c768aead-153b-42f3-bb4d-b06e30ebad80	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
P25 Progesterone Cream	PROGESTERONE	SHYNE BRANDS	c47169b7-1b6a-2ad0-e053-2995a90a0b19	2025-06-01	Warnings	Name fallback generic name: PROGESTERONE
P75 Lav Progesterone Cream	PROGESTERONE	SHYNE BRANDS	c4711337-7c1f-3556-e053-2a95a90a7b82	2025-06-01	Warnings	Name fallback generic name: PROGESTERONE
P50 Progesterone Cream	PROGESTERONE	SHYNE BRANDS	c47121df-6c04-b273-e053-2a95a90aa549	2025-06-01	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	BioActive Nutritional, Inc.	0de91238-dacc-4a5c-86d8-ad94024b2c95	2025-05-20	Warnings	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	0aeb0f0f-2749-416b-942f-83950200fd75	2025-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Asclemed USA, Inc.	342a096d-df6f-47de-bdd1-ec259638e476	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	XIROMED, LLC	dcfa4050-d142-b774-369f-8a421eb23c62	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83419	ORIG	2025-09-23