Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 12
- Live patents
- 0
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Larken Laboratories, Inc.Registrant: Larken Laboratories, Inc | 276 Nissan Parkway Building A, Suite 200, Canton, Mississippi (MS) 39046-7006, United States (USA) | Labelling | 3005966786149484540 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 7 human prescription drug, 5 human otc drug. By marketing category: ANDA 5, OTC MONOGRAPH DRUG 5, UNAPPROVED DRUG OTHER 2.
| Dosage form | NDCs |
|---|---|
| tablet | 6 |
| liquid | 5 |
| tablet, orally disintegrating | 1 |
| Route | NDCs |
|---|---|
| oral | 11 |
| sublingual | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| larken laboratories, inc. | 12 |
Catalogue
Marketed products
12| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ALLZITAL | butalbital and acetaminophen | tablet, oral | 68047-752ANDA |
| Butalbital And Acetaminophen | butalbital and acetaminophen | tablet, oral | 68047-721ANDA |
| Butalbital and Acetaminophen | butalbital and acetaminophen | tablet, oral | 68047-753ANDA |
| Dexamethasone 1.5 mg | Dexamethasone 1.5 mg | tablet, oral | 68047-702ANDA |
| Doxycycline Hyclate | Doxycycline Hyclate | tablet, oral | 68047-714ANDA |
| EndaCof DM | Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | liquid, oral | 68047-143OTC MONOGRAPH DRUG |
| LoHist D | Chlorpheniramine Maleate / Pseudoephedrine HCl | liquid, oral | 68047-120OTC MONOGRAPH DRUG |
| LoHist DM | Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | liquid, oral | 68047-129OTC MONOGRAPH DRUG |
| LoHist-D | Chlorpheniramine Maleate / Pseudoephedrine HCl | liquid, oral | 68047-159OTC MONOGRAPH DRUG |
| NoHist DM | Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | liquid, oral | 68047-186OTC MONOGRAPH DRUG |
| OSCIMIN | Hyoscyamine Sulfate | tablet, oral | 68047-252UNAPPROVED DRUG OTHER |
| OSCIMIN | Hyoscyamine Sulfate | tablet, orally disintegrating, sublingual | 68047-253UNAPPROVED DRUG OTHER |
Neighbours
Registered in the same town
2- Allegis Pharmaceuticals, Inc.Canton, MS · 2 sites
- Derm Ventures, LLCCanton, MS
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Enquiry
Common questions
- Is Larken Laboratories, Inc FDA approved?
- Larken Laboratories, Inc holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Larken Laboratories, Inc's registered sites?
- The FDA register lists Canton, MS. Registered operations: labelling.
- What drugs does Larken Laboratories, Inc make?
- 12 products are listed under Larken Laboratories, Inc in the openFDA NDC Directory, most often as tablet; liquid; tablet, orally disintegrating. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.