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 3 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Newton Laboratories, Inc.	9e038e0b-a124-1870-e053-2995a90a49f8	2025-02-10	Warnings	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Direct Rx	dc9e2088-e11e-7d32-e053-2a95a90a2995	2025-01-22	Warnings	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	direct rx	c33e6c10-3149-57c3-e053-2995a90a3fa1	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone Phenolic	PROGESTERONE	Energique, Inc.	177c7d38-d133-4e3b-a81e-f6bacd39b147	2024-10-29	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Fresenius Kabi USA, LLC	a479b395-1e1a-4d2a-8feb-68a15c47225f	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1220b231-4765-4879-acb8-d7887d863a28	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0d976866-81b3-5db8-e063-6294a90a39f9	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	Hikma Pharmaceuticals USA Inc.	83cfc12e-75d1-4284-bcc3-beadcbd27171	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	80a63b2b-96be-423d-abbd-13acc802f6da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Crinone	PROGESTERONE	Allergan, Inc.	75e97aa1-daa4-45f9-b2e2-1a371302914e	2024-05-21	Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1c71a4b0-1347-498f-8124-f4cb4be27b61	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	b74caa23-a5b8-42dd-ab48-4b7a2f015deb	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Deseret Biologicals, Inc.	ef33af80-5f72-4635-a8ae-f48376efb451	2024-03-14	Warnings	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Dr. Reddys Laboratories, Inc.	efded380-02ff-68c9-13e4-47a561ede440	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Aurobindo Pharma Limited	7d73f08d-2de7-44b6-9e44-2d488fe02517	2024-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	96c59a1c-d562-46dd-868b-b2decdfef319	2023-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Eugia US LLC	7d19df3b-94ed-4681-beae-9caaf137d014	2023-09-12	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2023-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	5e0263c5-2cb6-4e02-b883-2c05492a6260	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone Combo	PROGESTERONE	Nutritional Specialties, Inc.	5ccf7bee-2da4-4347-8753-30680d7c1c03	2023-04-27	Warnings	Name fallback 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