Last updated: June 23, 2026
NYLIA 1/35 is a combined oral contraceptive (COC) containing ethinyl estradiol 0.035 mg and norethindrone 1 mg. No supplier/manufacturer or distribution roster can be produced from the information provided.
Who are the suppliers for NYLIA 1/35 (ethinyl estradiol 0.035 mg/norethindrone 1 mg)?
A supplier answer requires identifying the labeled manufacturer and/or listed distributor on the marketed product, typically via FDA labeling, the Orange Book record for the NDA ANDA holders, wholesaler/distributor listings, and product package insert identifiers (application holder and manufacturing site).
No such sourcing data was provided.
What entities typically show up as suppliers for 1/35 COCs?
For U.S. marketed COCs, the “supplier” role usually maps to one or more of the following:
- Applicant holder / NDA holder listed on FDA labeling
- Manufacturing site(s) listed in the drug product labeling and FDA databases
- Marketing authorization holder for the brand
- Authorized distributors and wholesalers serving retail and hospital channels
No NYLIA 1/35 label-verified entity list is available in the prompt.
What does the Orange Book list for NYLIA 1/35: application holder, strength, and exclusivity?
An Orange Book-based supplier list must pull:
- Drug product (NDC and dosage form)
- Application type (NDA or ANDA)
- Application holder
- Patent listings tied to the listed drug
The prompt provides no NDC, FDA application number, or Orange Book listing identifiers, so a complete and accurate Orange Book extract cannot be created.
What manufacturers produce NYLIA 1/35 tablets (dosage form and site-level data)?
Manufacturer and site-level sourcing requires:
- Product label “Manufactured for” or “Manufactured by” statements
- Site identifiers (establishment codes) tied to the drug product
Those data are not present in the input.
Is NYLIA 1/35 the brand of an ANDA, and who is the generic/brand supplier?
Determining whether NYLIA 1/35 is:
- an innovator NDA product, or
- a branded formulation of an ANDA (authorized brand),
requires an FDA application lookup by brand name and strength.
No FDA identifiers were provided, so the supplier mapping cannot be completed.
How do NYLIA 1/35 suppliers compare with other ethinyl estradiol/norethindrone 1/35 brands?
A comparison requires a matched dataset across competing brands (Orange Book holder, NDCs, and labeled manufacturers).
No competing-brand or NDC set is included, so an evidence-backed comparison cannot be produced.
What patent estate does NYLIA 1/35 have that affects supplier licensing?
Supplier licensing and manufacturing rights often correlate with NDA/ANDA ownership and listed patents (composition, method-of-use, and formulation). This must be pulled from FDA patent listings by application.
The prompt provides none of the needed patent record inputs.
What is the FDA regulatory status of NYLIA 1/35 and does it indicate multiple sources?
FDA status (approved labeling, manufacturing changes, authorized generics, or multiple NDA/ANDA sources) is determined from FDA approval and listing history.
No FDA regulatory artifacts or application records are provided.
What generic entry risks exist for NYLIA 1/35 that could change the supplier base?
Generic entry risk is tied to patent expiry, exclusivities, and Paragraph IV or section 505(b)(2) challenges, plus settlement outcomes.
No Orange Book or litigation data is included, so no supplier-risk assessment can be made.
Key Takeaways
- NYLIA 1/35 is a ethinyl estradiol/norethindrone COC (1 mg/0.035 mg).
- A supplier list (manufacturers, marketing authorization holder, distributors, and site-level producers) cannot be generated from the information provided.
FAQs
- How can I identify the labeled manufacturer of NYLIA 1/35?
- Is NYLIA 1/35 an NDA or ANDA listed drug in the Orange Book?
- Which NDC corresponds to NYLIA 1/35, and who is the application holder?
- Do NYLIA 1/35 tablets have multiple manufacturing sites listed on FDA records?
- How do authorized generic arrangements affect who supplies NYLIA 1/35 in the U.S.?
References
No sources were provided or cited.
