Application 020130

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTROSTEP 21	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ESTROSTEP FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	Yes	Yes

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

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
N020130-001	ESTROSTEP 21	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09
N020130-002	ESTROSTEP FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28		RLD	1996-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28		RLD	1996-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		RLD	1996-10-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28	AB	RLD, RS	1996-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1996-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28		RLD	1996-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020130-001	ESTROSTEP 21	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1996-10-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020130-002	ESTROSTEP FE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET / ORAL-28		RLD	1996-10-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020130-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020130-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020130-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020130-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020130-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020130-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020130-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020130-002	AB	1	`ea99ee380514…`

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0005	ESTROSTEP Fe	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Allergan, Inc.	NDA	Current
0430-0005	ESTROSTEP Fe	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Allergan, Inc.	NDA	Current
0430-0005	ESTROSTEP Fe	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Allergan, Inc.	NDA	Current
0430-0005	ESTROSTEP Fe	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Allergan, Inc.	NDA	Current
51862-284	Tilia Fe	Norethindrone Acetate and Ethinyl Estradiol	Mayne Pharma Inc.	NDA	Current
51862-284	Tilia Fe	Norethindrone Acetate and Ethinyl Estradiol	Mayne Pharma Inc.	NDA	Current
51862-284	Tilia Fe	Norethindrone Acetate and Ethinyl Estradiol	Mayne Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70970	SUPPL	2022-05-04
70927	SUPPL	2022-05-03
68107	SUPPL	2021-07-16
68091	SUPPL	2021-07-15
50031	SUPPL	2017-10-12
50012	SUPPL	2017-10-11
49420	SUPPL	2017-08-15
49305	SUPPL	2017-08-09
12239	SUPPL	2003-04-25
2050	SUPPL	2002-06-14
41149	SUPPL	1999-05-07