Last updated: June 3, 2026
PREMPHASE 14/14 suppliers: Who manufactures the Premphase 14/14 drug product and API across the supply chain?
Which companies supply the API and finished dose for PREMPHASE 14/14 (levonorgestrel–ethinyl estradiol extended-cycle oral contraceptive)?
No sufficient source data is available to identify specific PREMPHASE 14/14 API or finished-dose suppliers, contract manufacturers, or labeler/manufacturer entries.
Because supplier names for a specific branded product must be verified from authoritative listings (eg, FDA CDER labeling, Orange Book “Applicant/Manufacturer” fields, Drugs@FDA, SPL product labels, or facility/assignment data), and because none of those product-specific records are provided here, a complete and accurate supplier map cannot be produced.
What does the Orange Book list for PREMPHASE 14/14 (applicant, manufacturer, and patent-linked product details)?
No sufficient information is available to extract Orange Book applicant or manufacturer listings for PREMPHASE 14/14.
Who is the labeler of record for PREMPHASE 14/14, and does it indicate contract manufacturing?
No sufficient product labeler/manufacturer-of-record details are provided to identify the labeler and any contract manufacturing partner(s).
Which contract manufacturing organizations (CMOs) produce PREMPHASE 14/14 tablets or blister packs?
No sufficient manufacturing attribution data is available to name any CMO(s) for PREMPHASE 14/14.
How does PREMPHASE 14/14 packaging (blister, bottle, NDC presentation) affect supplier identification?
No sufficient NDC-level presentation data is available to tie PREMPHASE 14/14 packaging variants to distinct manufacturers or warehouses.
Do different strengths or pack sizes of PREMPHASE 14/14 use different suppliers?
No sufficient strength/pack-size mapping is available to determine whether supplier changes occur across PREMPHASE 14/14 presentations.
What are the regulatory and quality data points that would confirm PREMPHASE 14/14 suppliers?
No supplier-confirming dataset is available in the prompt (eg, FDA establishment registration linkages, inspection history tied to the product, or product-specific labeling “Manufactured for” statements).
Key Takeaways
- Supplier identification for PREMPHASE 14/14 cannot be completed from the information provided.
- No authoritative Orange Book / Drugs@FDA / labeling fields are included to name API suppliers, finished-dose manufacturers, or CMOs.
FAQs
- How can I determine the applicant and manufacturer of PREMPHASE 14/14 in the FDA Orange Book?
- Where on the PREMPHASE 14/14 FDA label do “manufactured for” and distributor statements appear that identify suppliers?
- Does FDA Drugs@FDA list separate manufacturers for different NDC presentations of PREMPHASE 14/14?
- Can PREMPHASE 14/14 supplier changes be detected by comparing historical label versions or revisions?
- What sources most reliably identify API vs finished-dose manufacturing for oral contraceptive brands like PREMPHASE 14/14?
References
- FDA. Drugs@FDA product label and approval history (access required).
- FDA. Orange Book listings for PREMPHASE 14/14 (access required).
