Application 091453

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LARIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	0.03MG;1.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091453-001	LARIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-28	AB		2013-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091453-001	AB

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 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091453-001	LARIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2013-08-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091453-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091453-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091453-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091453-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091453-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091453-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091453-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091453-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091453-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091453-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091453-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091453-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091453-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091453-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091453-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091453-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091453-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091453-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091453-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091453-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091453-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091453-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091453-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091453-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091453-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091453-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091453-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091453-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091453-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091453-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091453-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091453-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091453-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091453-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091453-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091453-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091453-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091453-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091453-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091453-001	AB	1	`cb3db0bc1861…`

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Larin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Northstar Rx LLC	ee79a7fa-1c64-4b7b-822c-e0ddefc8ef86	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091453 application number: ANDA091453 ndc (product): 16714-405
Microgestin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Dr. Reddys Laboratories Inc	17b4ee33-3ec1-440d-9446-f20c51629c2d	2024-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091453 application number: ANDA091453
Microgestin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Proficient Rx LP	03053e47-c9ac-42bd-b4cd-3e911564676a	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091453 application number: ANDA091453
Microgestin Fe 1.5/30	NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE	Mayne Pharma Inc.	1587721b-0d71-4fe7-9e34-eac41a115203	2020-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091453 application number: ANDA091453 ndc (product): 51862-870

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-405	Larin Fe 1.5/30	Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate	Northstar Rx LLC	ANDA	Current
50090-2559	Larin Fe 1.5/30	Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate	A-S Medication Solutions	ANDA	Current
51862-870	Microgestin Fe 1.5/30	Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate	Mayne Pharma Inc.	ANDA	Current