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 4 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Asclemed USA, Inc.	19716042-8025-43a3-b26d-e0fd7d2587eb	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	efd6a8d8-c023-4d9f-b574-b14dc945203d	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	4a741977-1dbb-41e7-a560-9ac02936f8b1	2022-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	e1546b35-cfa8-4808-9652-db1ba675a4e3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	73e65b35-2266-48a3-98f8-521446a55c22	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	3acad9b0-7ec6-4d5e-9852-32ffadbbed6d	2018-03-11	Boxed warning, 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