FDA application holder
DR Reddys Laboratories Sa
The Orange Book identifies this organization as the applicant responsible for ANDA 076625.
Orange Book drug · Generic (ANDA)
Levonorgestrel And Ethinyl Estradiol
Ethinyl Estradiol; Levonorgestrel
ANDA 076625 DR Reddys Labs Sa
Approved
Nov 18, 2004
Strengths
1
Listed patents
0
Applications
21
What does the FDA Orange Book show for Levonorgestrel And Ethinyl Estradiol?
Levonorgestrel And Ethinyl Estradiol contains Ethinyl Estradiol; Levonorgestrel and appears in 21 FDA Orange Book applications. ANDA 076625 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
- 21; lead ANDA 076625
- Lead application holder
- DR Reddys Laboratories Sa
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RS
- TE codes
- AB1
- 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 | 0.02MG;0.1MG | TABLETORAL-28 | Prescription | AB1 | 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 AB1 across rated presentations
FDA considers products with the same AB1 code therapeutically equivalent within the same active ingredient, dosage form, route, and strength heading. A different numbered AB code is a different 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
40 other ANDAs and 15 other NDAs found
27 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 076625 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; Levonorgestrel
- Product rows
- 36
- Active applications
- 23
- Active with AB row
- 23
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-076625
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 076625
TE AB1RS
- Strength
- 0.02MG;0.1MG
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
22 yr ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Strength
0.02MG;0.1MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB1
Application
ANDA 076625
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 Levonorgestrel And Ethinyl Estradiol
20 additional filings · 20 generic
The FDA has approved 21 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 077681 | DR Reddys Labs Sa | May 31, 2006 | 1 | AB2 | Prescription |
| ANDA 079218 | Watson Labs | Jun 06, 2011 | 1 | AB | Prescription |
| ANDA 075862 | Barr | Apr 29, 2003 | 2 | — | Discontinued |
| ANDA 091425 | Lupin Ltd | Jan 18, 2013 | 1 | AB1 | Prescription |
| ANDA 091440 | Lupin Ltd | Oct 23, 2012 | 1 | AB | Prescription |
| ANDA 091663 | Xiromed | Dec 21, 2012 | 1 | AB | Prescription |
| ANDA 200245 | Xiromed | Oct 09, 2013 | 1 | AB1 | Prescription |
| ANDA 200248 | Lupin | Nov 19, 2015 | 1 | AB | Prescription |
| ANDA 200490 | Xiromed | Apr 21, 2015 | 1 | AB | Prescription |
| ANDA 201095 | Amneal Pharms | Dec 08, 2014 | 1 | — | Discontinued |
| ANDA 201108 | Amneal Pharms | Feb 05, 2014 | 1 | — | Discontinued |
| ANDA 202247 | Xiromed | Dec 08, 2014 | 1 | — | Discontinued |
| ANDA 202791 | Glenmark Pharms Ltd | Apr 09, 2015 | 1 | AB | Prescription |
| ANDA 202970 | Xiromed | Mar 23, 2018 | 1 | — | Discontinued |
| ANDA 203164 | Glenmark Pharms Ltd | Jun 12, 2015 | 1 | AB | Prescription |
| ANDA 203871 | Naari Pte | Nov 13, 2015 | 1 | AB | Prescription |
| ANDA 203872 | Naari Pte | Dec 22, 2015 | 1 | AB | Prescription |
| ANDA 207033 | Naari Pte | Oct 09, 2020 | 1 | AB | Prescription |
| ANDA 207065 | Naari Pte | Aug 17, 2020 | 1 | AB1 | Prescription |
| ANDA 212298 | Hetero Labs | Feb 13, 2023 | 1 | AB1 | Prescription |
Active-ingredient family
Brand + generics
Generic (ANDA) of Ethinyl Estradiol; Levonorgestrel
- 2020TyblumeBrand (NDA)
NDA 209405 · Exeltis USA Inc
- 2020TwirlaBrand (NDA)
NDA 204017 · Agile
- 2018BalcoltraBrand (NDA)
NDA 208612 · Avion Pharms
- 2013QuartetteBrand (NDA)
NDA 204061 · Teva Branded Pharm
- 2008LoseasoniqueBrand (NDA)
NDA 022262 · Teva Branded Pharm
- 2007LybrelBrand (NDA)
NDA 021864 · Wyeth Pharms Inc
- 2006SeasoniqueBrand (NDA)
NDA 021840 · Teva Branded Pharm
- 2003SeasonaleBrand (NDA)
NDA 021544 · Teva Branded Pharm
- 1998Preven Emergency Contraceptive KitBrand (NDA)
NDA 020946 · Teva Branded Pharm
- 1998LevliteBrand (NDA)
NDA 020860 · Bayer Hlthcare
- 1997AlesseBrand (NDA)
NDA 020683 · Cadence Health
- 1984Triphasil-21Brand (NDA)
NDA 019192 · Wyeth Pharms
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.
Levonorgestrel 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 076625 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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