Last updated: April 24, 2026
OXYTROL FOR WOMEN is a branded formulation of oxybutynin delivered via a transdermal system. Public labeling and FDA-facing documentation tie the product to Pfizer (marketing authorization holder for OXYTROL and OXYTROL for Women) and to Pharma Tech Industries, Inc. (license holder for the U.S. Abbreviated New Drug Application listed under this brand). No other named third-party suppliers are consistently identified in the public product record set.
What companies are listed on the U.S. product record?
Brand marketing and licensing
| Item |
Entity |
What it means in practice |
Source |
| Marketing authorization holder / NDA holder (brand record) |
Pfizer Laboratories Division of Pfizer Inc. |
Listed as the company responsible for the branded product submission/market |
FDA Orange Book entry for OXYTROL [1] |
| U.S. license holder for listed application under the brand |
Pharma Tech Industries, Inc. |
Listed as the company tied to the underlying application reference record in the Orange Book |
FDA Orange Book entry for OXYTROL [1] |
Which supply chain roles are publicly identifiable from the record?
| Role |
Publicly named in record? |
Who is named |
| NDA/brand holder (responsibility for branded submission) |
Yes |
Pfizer Laboratories Division of Pfizer Inc. [1] |
| Listed license holder tied to the Orange Book application record |
Yes |
Pharma Tech Industries, Inc. [1] |
| Manufacturing site (facility-level supplier) |
Not identified in the provided public record excerpt |
Not determinable from the Orange Book entry alone |
| API supplier for oxybutynin |
Not identified in the provided public record excerpt |
Not determinable from the Orange Book entry alone |
| Transdermal system supplier (patch manufacturer) |
Not identified in the provided public record excerpt |
Not determinable from the Orange Book entry alone |
What does the FDA record say about the active ingredient and form (for supplier scoping)?
OXYTROL FOR WOMEN is a transdermal delivery system of oxybutynin. That form matters because it typically involves at least two supply categories: (1) drug substance and (2) a specialized transdermal manufacturing process (adhesive matrix plus backing/liner plus rate-controlling structure). The U.S. Orange Book entry used for brand linkage identifies company records, not patch production contractors at a facility level [1].
Drug, dose form, and product scope
- Active ingredient: oxybutynin
- Dosage form: transdermal system
- Brand: OXYTROL / OXYTROL FOR WOMEN (marketed as the overactive bladder patch product) [1]
Supplier takeaways for R&D or procurement planning
- Brand-facing responsibility in the U.S. sits with Pfizer on the FDA brand record. If you are mapping regulatory responsibility or branded-submission ownership, Pfizer is the named entity [1].
- The Orange Book application record also lists Pharma Tech Industries, Inc. as a license holder tied to the application record associated with the brand. This is the second named corporate supplier-adjacent entity in the public FDA record set [1].
- No facility-level patch manufacturer, API vendor, or contract supplier is explicitly named in the cited Orange Book brand entry. Any facility or contractor list would require separate inspection of manufacturing-authorizations or product-specific CMC disclosures not present in the cited record.
Key Takeaways
- Pfizer Laboratories Division of Pfizer Inc. is the named company on the FDA brand record for OXYTROL (covers the branded transdermal oxybutynin product marketed as OXYTROL FOR WOMEN) [1].
- Pharma Tech Industries, Inc. is listed as the license holder on the FDA Orange Book entry associated with the brand record [1].
- The cited FDA record identifies corporate record holders, not plant/facility-level or API/patch contractor suppliers.
FAQs
1) Who is the primary U.S. company tied to the OXYTROL FOR WOMEN brand record?
Pfizer Laboratories Division of Pfizer Inc. [1]
2) Is Pharma Tech Industries, Inc. listed for OXYTROL in the FDA record?
Yes. The Orange Book entry lists Pharma Tech Industries, Inc. as a license holder tied to the brand record [1].
3) Do FDA Orange Book entries name the API supplier for oxybutynin used in OXYTROL?
Not in the cited record set. The Orange Book entry used here lists corporate holders, not API vendors [1].
4) Do FDA Orange Book entries name the patch manufacturer facilities for OXYTROL FOR WOMEN?
Not in the cited record set. Facility-level suppliers are not identified in the Orange Book entry referenced here [1].
5) What form of oxybutynin is OXYTROL FOR WOMEN?
It is a transdermal system (patch) formulation of oxybutynin [1].
References
[1] FDA. (n.d.). OXYTROL (oxybutynin) transdermal system; Orange Book drug product information. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
