Orange Book drug · Generic (ANDA)

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

Ethinyl Estradiol; Norethindrone Acetate

ANDA 210369 Glenmark Pharms Ltd

Approved

Dec 26, 2017

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate?

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate contains Ethinyl Estradiol; Norethindrone Acetate across 11 FDA applications. ANDA 210369 is the lead filing; other filings are listed separately. This page preserves Orange Book facts and source limits. Clinical labeling requires an exact application-matched source.

FDA applications: 11; lead ANDA 210369
Lead application holder: Glenmark Pharmaceuticals Ltd
Product presentations: 1
Marketing categories: Prescription
Reference roles: RS
TE codes: AB
Listed patents: 0
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	0.02MG;1MG	TABLETORAL	Prescription	AB	RS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Glenmark Pharmaceuticals Ltd

The Orange Book identifies this organization as the applicant responsible for ANDA 210369.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

48 other ANDAs and 15 other NDAs found

37 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 210369 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Ethinyl Estradiol; Norethindrone Acetate

27 applications

Product rows: 31
Active applications: 14
Active with AB row: 13

Minastrin 24 Fe · NDA 203667 Lo Loestrin Fe · NDA 022501 Loestrin 24 Fe · NDA 021871 Femhrt · NDA 021065 Oshih · ANDA 216558 Finzala · ANDA 210087

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-210369

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

ANDA 210369

TE ABRS

Strength: 0.02MG;1MG
Dosage form: TABLET
Route: ORAL
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Dec 26, 2017
8 yr 8 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.02MG;1MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 210369

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Other FDA applications for Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

10 additional filings · 10 generic

The FDA has approved 11 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 078267	Amneal Pharms	Sep 01, 2009	1	—	Discontinued
ANDA 090938	Barr Labs	Dec 01, 2014	1	AB	Prescription
ANDA 202742	Xiromed	Oct 30, 2014	1	—	Discontinued
ANDA 206120	Xiromed	Sep 12, 2017	1	—	Discontinued
ANDA 207514	Amneal Pharms	Sep 11, 2017	1	—	Discontinued
ANDA 208639	Apotex	Mar 21, 2018	1	—	Discontinued
ANDA 209609	Xiromed	Jul 16, 2018	1	AB	Prescription
ANDA 213418	Glenmark Pharms Ltd	Jul 27, 2022	1	AB	Prescription
ANDA 213901	DR Reddys Labs Sa	Apr 28, 2022	1	—	Discontinued
ANDA 214292	Amneal Pharms	Jul 20, 2021	1	—	Discontinued

Active-ingredient family

Brand + generics

Generic (ANDA) of Ethinyl Estradiol; Norethindrone Acetate

View full Ethinyl Estradiol; Norethindrone Acetate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.