FDA application holder
Glenmark Pharmaceuticals Ltd
The Orange Book identifies this organization as the applicant responsible for ANDA 200494.
Orange Book drug · Generic (ANDA)
Norgestimate And Ethinyl Estradiol
Ethinyl Estradiol; Norgestimate
ANDA 200494 Glenmark Pharms Ltd
Approved
Jun 17, 2011
Strengths
1
Listed patents
0
Applications
17
What does the FDA Orange Book show for Norgestimate And Ethinyl Estradiol?
Norgestimate And Ethinyl Estradiol contains Ethinyl Estradiol; Norgestimate and appears in 17 FDA Orange Book applications. ANDA 200494 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.
- FDA applications
- 17; lead ANDA 200494
- Lead application holder
- Glenmark Pharmaceuticals Ltd
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RS
- TE codes
- AB
- Listed patents
- 0
- Exclusivity records
- 0
Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLETORAL-28 | 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
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
14 other ANDAs and 3 other NDAs found
12 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 200494 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-28
Ethinyl Estradiol; Norgestimate
- Product rows
- 34
- Active applications
- 21
- Active with AB row
- 21
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-200494
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 200494
TE ABRS
- Strength
- 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
15 yr 4 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
ANDA 200494
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Listed patents
Orange Book patent fileNo 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 Norgestimate And Ethinyl Estradiol
16 additional filings · 16 generic
The FDA has approved 17 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.
| Application | Applicant | Approved | Strengths | TE code | Status |
|---|---|---|---|---|---|
| ANDA 204057 | Glenmark Speclt | Feb 23, 2016 | 1 | AB | Prescription |
| ANDA 076626 | Watson Labs | Aug 17, 2006 | 1 | — | Discontinued |
| ANDA 076627 | Watson Labs | Aug 17, 2006 | 1 | — | Discontinued |
| ANDA 090479 | Watson Labs | Mar 09, 2011 | 1 | — | Discontinued |
| ANDA 200383 | Naari Pte | Apr 07, 2015 | 1 | AB | Prescription |
| ANDA 200384 | Naari Pte | Apr 07, 2015 | 1 | AB | Prescription |
| ANDA 200538 | Glenmark Pharms Ltd | Apr 05, 2012 | 1 | AB | Prescription |
| ANDA 200541 | Lupin Pharms | Jun 25, 2012 | 1 | AB | Prescription |
| ANDA 201896 | Mylan | Jan 27, 2016 | 1 | — | Discontinued |
| ANDA 201897 | Xiromed | Jan 27, 2016 | 1 | — | Discontinued |
| ANDA 202132 | Xiromed | Sep 09, 2015 | 1 | — | Discontinued |
| ANDA 203865 | Naari Pte | Oct 27, 2015 | 1 | — | Discontinued |
| ANDA 203870 | Naari Pte | Nov 12, 2015 | 1 | — | Discontinued |
| ANDA 203873 | Naari Pte | May 12, 2016 | 1 | AB | Prescription |
| ANDA 205588 | Lupin | Apr 26, 2016 | 1 | AB | Prescription |
| ANDA 205630 | Lupin | Oct 27, 2016 | 1 | AB | Prescription |
Active-ingredient family
Brand + generics
Generic (ANDA) of Ethinyl Estradiol; Norgestimate
- 2002Ortho Tri-cyclen LoBrand (NDA)
NDA 021241 · Janssen Pharms
- 1992Ortho Tri-cyclenBrand (NDA)
NDA 019697 · Janssen Pharms
- 1989Ortho Cyclen-21Brand (NDA)
NDA 019653 · Janssen Pharms
- 2022Tri-lo-linyahGeneric (ANDA)
ANDA 090541 · Novast Labs
- 2016Tri-lo-miliGeneric (ANDA)
ANDA 205762 · Aurobindo Pharma
- 2016MiliGeneric (ANDA)
ANDA 205449 · Aurobindo Pharma Ltd
- 2016Tri-miliGeneric (ANDA)
ANDA 205441 · Aurobindo Pharma Ltd
- 2015Tri-lo-estaryllaGeneric (ANDA)
ANDA 091232 · Xiromed
- 2013EstaryllaGeneric (ANDA)
ANDA 090794 · Xiromed
- 2013Tri-estaryllaGeneric (ANDA)
ANDA 090793 · Xiromed
- 2012Tri-linyahGeneric (ANDA)
ANDA 090524 · Novast Labs Ltd
- 2012Mono-linyahGeneric (ANDA)
ANDA 090523 · Novast Labs Ltd
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
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
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.
Norgestimate And Ethinyl Estradiol: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of ANDA 200494 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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