Last Updated: May 24, 2026

Suppliers and packagers for tri-linyah


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tri-linyah

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524 ANDA Northstar Rx LLC 16714-363-01 1 BLISTER PACK in 1 PACKET (16714-363-01) / 1 KIT in 1 BLISTER PACK 2012-05-30
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524 ANDA Northstar Rx LLC 16714-363-02 1 BLISTER PACK in 1 CARTON (16714-363-02) / 1 KIT in 1 BLISTER PACK 2012-05-30
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524 ANDA Northstar Rx LLC 16714-363-03 3 BLISTER PACK in 1 CARTON (16714-363-03) / 1 KIT in 1 BLISTER PACK 2012-05-30
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524 ANDA Northstar Rx LLC 16714-363-04 6 BLISTER PACK in 1 CARTON (16714-363-04) / 1 KIT in 1 BLISTER PACK 2012-05-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for tri-linyah

Last updated: May 24, 2026

Tri-Linyah Drug Suppliers: Who Manufactures, Packages, and Supplies the Product for Distribution?

What is Tri-Linyah and which companies supply it?

No complete, verifiable drug identity or FDA-market product record is available to map “Tri-Linyah” to a specific active ingredient(s), dosage form, strength, and labeler on FDA systems or commercially available registries. Without that mapping, supplier identification would be incomplete and risk misattribution.

What active ingredient and NDC does Tri-Linyah correspond to?

A supplier supply-chain map requires a stable identifier (active ingredient(s) + dosage form/strength, or an FDA/NDC listing). “Tri-Linyah” alone does not provide enough specificity to connect to an Orange Book / Drug Product Database listing or a labeler/manufacturer network.

How do you identify Tri-Linyah suppliers from FDA drug listings (labeler, manufacturer, packager)?

Supplier identification typically comes from three FDA data points:

  • Labeler (Marketing authorization holder)
  • Manufacturer (site/establishment tied to drug substance or drug product manufacturing)
  • Packager/Distributor (packaging and release roles)

No Tri-Linyah labeler record can be reliably determined from the provided term.

What is the Orange Book status of Tri-Linyah and which labelers are listed?

Orange Book listing requires a specific NDA/ANDA/BLA match. No Orange Book match can be asserted for “Tri-Linyah” without the underlying NDA/ANDA and product identity.

Which generic, authorized generic, or parallel import suppliers exist for Tri-Linyah?

Generic and authorized generic risk depends on:

  • FDA approval pathway (NDA vs ANDA)
  • Patent estate (Orange Book patents and exclusivity)
  • Launch/marketing status No Tri-Linyah approval record can be connected from the provided name alone, so supplier existence cannot be established.

What manufacturers and contract development and manufacturing organizations (CDMOs) supply Tri-Linyah?

CDMO and contract manufacturing assignments require:

  • Firm/establishment linkage from FDA drug product records
  • Inspection/establishment number mapping No establishment-linked mapping can be derived for “Tri-Linyah” without the corresponding FDA product identifiers.

Key Takeaways

  • “Tri-Linyah” as provided is not sufficient to identify the correct FDA product record, labeler, NDC, or manufacturing/packaging sites.
  • A reliable supplier list cannot be produced without a verifiable mapping to the specific drug identity used in FDA systems.

FAQs

  1. How can I find the labeler and manufacturer for a named drug without an NDC?
  2. What FDA database fields identify drug product manufacturing vs packaging vs distribution?
  3. How do I determine whether a brand has authorized generics and who sells them?
  4. Where does Orange Book listing link to the NDA/ANDA that drives supplier identification?
  5. What evidence supports a CDMO-to-brand manufacturing claim (FDA establishment data)?

References

  1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA website).
  2. U.S. Food and Drug Administration. Drugs@FDA. (FDA website).
  3. U.S. Food and Drug Administration. National Drug Code Directory (NDC). (FDA website).

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