Application 202121

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROGESTERONE	PROGESTERONE	CAPSULE;ORAL	100MG	No	No
002	PROGESTERONE	PROGESTERONE	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202121-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL			2012-02-29
A202121-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL			2012-02-29

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202121-001	PROGESTERONE	100MG	CAPSULE / ORAL	2012-02-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202121-002	PROGESTERONE	200MG	CAPSULE / ORAL	2012-02-29	`74a2ff9319b5…`

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 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5353	Progesterone	Progesterone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5353	Progesterone	Progesterone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5354	Progesterone	Progesterone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5354	Progesterone	Progesterone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
71335-0713	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-0713	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44578	ORIG	2013-06-04
24101	SUPPL	2013-06-04
44579	SUPPL	2012-10-15
24100	ORIG	2012-10-15
43386	ORIG	2012-10-09
22871	SUPPL	2012-10-09