Application 075548

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICROGESTIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-28	0.03MG;1.5MG	No	No
002	MICROGESTIN 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL-21	0.03MG;1.5MG	No	No

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
A075548-001	MICROGESTIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-28			2001-02-05
A075548-002	MICROGESTIN 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET / ORAL-21			2003-07-30

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28	AB	2001-02-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21	AB	2003-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075548-001	MICROGESTIN FE 1.5/30	0.03MG;1.5MG	TABLET / ORAL-28		2001-02-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075548-002	MICROGESTIN 1.5/30	0.03MG;1.5MG	TABLET / ORAL-21		2003-07-30	`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	A075548-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075548-002	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A075548-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075548-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075548-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075548-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075548-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075548-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075548-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075548-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075548-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075548-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075548-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075548-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075548-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075548-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075548-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075548-002	AB	1	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Name fallback brand name: Microgestin Fe 1.5/30
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	Name fallback brand name: Microgestin Fe 1.5/30
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	Name fallback brand name: Microgestin Fe 1.5/30

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
22483	ORIG	2013-05-02
30930	ORIG	2001-02-05