Register entry
Mayne Pharma International Pty Ltd.
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 63
- Labeller names
- 4
- Live patents
- 154
- Countries
- 1
- Base
- Australia
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Mayne Pharma International Pty Ltd. | 1538 Main North Road, Salisbury South, South Australia 5106, Australia (AUS) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004090027756003745 |
Catalogue
Drug listings by form and route
6363 active NDC listings: 53 human prescription drug, 10 drug for further processing. By marketing category: ANDA 37, DRUG FOR FURTHER PROCESSING 10, NDA 8, NDA AUTHORIZED GENERIC 8.
| Dosage form | NDCs |
|---|---|
| kit | 17 |
| capsule, liquid filled | 8 |
| aerosol, foam | 6 |
| cream | 6 |
| capsule, extended release | 5 |
| gel | 5 |
| tablet | 5 |
| capsule | 2 |
| capsule, delayed release pellets | 2 |
| capsule, gelatin coated | 1 |
| liquid | 1 |
| lotion | 1 |
| patch, extended release | 1 |
| ring | 1 |
| shampoo | 1 |
| Route | NDCs |
|---|---|
| topical | 19 |
| oral | 16 |
| transdermal | 1 |
| vaginal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| mayne pharma inc. | 29 |
| mayne pharma | 24 |
| mayne pharma international pty ltd | 6 |
| mayne pharma international pty ltd. | 4 |
Exclusivity
Patents and exclusivities
154| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7732430 | NEXTSTELLISdrospirenone; estetrol | product | Jan 2028 |
| 12156946 | EPSOLAY, TWYNEObenzoyl peroxide; benzoyl peroxide; tretinoin | product | Feb 2028 |
| 12350382 | EPSOLAYbenzoyl peroxide | product | Feb 2028 |
| 8617580 | TWYNEObenzoyl peroxide; tretinoin | product | Feb 2028 |
| 8715724 | DORYX, DORYX MPCdoxycycline hyclate | product | Feb 2028 |
| 7812049 | RHOFADEoxymetazoline hydrochloride | use | May 2028 |
| 8263580 | SORILUXcalcipotriene | product | May 2028 |
| 9868103 | EPSOLAY, TWYNEObenzoyl peroxide; benzoyl peroxide; tretinoin | product | Aug 2028 |
| 10568859 | FABIORtazarotene | product | Feb 2030 |
| 10688071 | FABIORtazarotene | product | Feb 2030 |
| 8808716 | FABIORtazarotene | product | Feb 2030 |
| 10653899 | TWYNEObenzoyl peroxide; tretinoin | product | Dec 2030 |
| 11071878 | TWYNEObenzoyl peroxide; tretinoin | product | Dec 2030 |
| 12070629 | TWYNEObenzoyl peroxide; tretinoin | product | Dec 2030 |
| 8883838 | RHOFADEoxymetazoline hydrochloride | product | Dec 2031 |
| 12053546 | TWYNEObenzoyl peroxide; tretinoin | product | Jun 2032 |
| 10052386 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 10206932 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 10258630 | IMVEXXYestradiol | use | Nov 2032 |
| 10398708 | IMVEXXYestradiol | use | Nov 2032 |
| 10471072 | IMVEXXYestradiol | use | Nov 2032 |
| 10537581 | IMVEXXYestradiol | product | Nov 2032 |
| 10568891 | IMVEXXYestradiol | use | Nov 2032 |
| 10639375 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 10668082 | IMVEXXYestradiol | use | Nov 2032 |
| 10675288 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 10806697 | IMVEXXYestradiol | product | Nov 2032 |
| 10806740 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 10835487 | IMVEXXYestradiol | use | Nov 2032 |
| 10888516 | IMVEXXYestradiol | use | Nov 2032 |
| 11033626 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 11065197 | IMVEXXYestradiol | product | Nov 2032 |
| 11103513 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 11103516 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 11110099 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 11116717 | IMVEXXYestradiol | product | Nov 2032 |
| 11123283 | IMVEXXYestradiol | product | Nov 2032 |
| 11166963 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 11241445 | IMVEXXYestradiol | use | Nov 2032 |
| 11246875 | IMVEXXYestradiol | use | Nov 2032 |
| 11304959 | IMVEXXYestradiol | product | Nov 2032 |
| 11351182 | IMVEXXYestradiol | use | Nov 2032 |
| 11497709 | IMVEXXYestradiol | use | Nov 2032 |
| 11529360 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 11793819 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 11865179 | BIJUVAestradiol; progesterone | substance, product | Nov 2032 |
| 8633178 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 8846648 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 8846649 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 8933059 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 8987237 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 8993548 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 8993549 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 9006222 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 9114145 | BIJUVAestradiol; progesterone | use | Nov 2032 |
| 9114146 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 9180091 | IMVEXXYestradiol | product | Nov 2032 |
| 9289382 | IMVEXXYestradiol | product | Nov 2032 |
| 9301920 | BIJUVAestradiol; progesterone | product | Nov 2032 |
| 9687465 | EPSOLAYbenzoyl peroxide | product | Nov 2032 |
Catalogue
Marketed products
64Showing 63 of 64.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Annovera | segesterone acetate and ethinyl estradiol | ring, vaginal | 68308-752NDA |
| Azurette | desogestrel/ethinyl estradiol and ethinyl estradiol | kit | 51862-890ANDA |
| - | Budesonide | capsule, delayed release pellets | 50546-580DRUG FOR FURTHER PROCESSING |
| CAMILA | NORETHINDRONE | tablet, oral | 51862-884ANDA |
| - | Carbidopa and Levodopa | tablet | 50546-077DRUG FOR FURTHER PROCESSING |
| - | Carbidopa and Levodopa | tablet | 50546-856DRUG FOR FURTHER PROCESSING |
| - | Carbidopa and Levodopa | tablet | 50546-858DRUG FOR FURTHER PROCESSING |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | gel, topical | 68308-127ANDA |
| Clonidine | CLONIDINE | patch, extended release, transdermal | 51862-455ANDA |
| DOXYCYCLINE | DOXYCYCLINE | capsule, oral | 68308-668NDA AUTHORIZED GENERIC |
| Dapsone | Dapsone | gel, topical | 51862-123ANDA |
| Desogestrel and Ethinyl Estradiol | Desogestrel and Ethinyl Estradiol | kit | 51862-514ANDA |
| - | Diltiazem Hydrochloride | capsule, extended release | 50546-328DRUG FOR FURTHER PROCESSING |
| - | Diltiazem Hydrochloride | capsule, extended release | 50546-329DRUG FOR FURTHER PROCESSING |
| - | Diltiazem Hydrochloride | capsule, extended release | 50546-330DRUG FOR FURTHER PROCESSING |
| ERRIN | NORETHINDRONE | tablet, oral | 51862-886ANDA |
| FABIOR | tazarotene | aerosol, foam, topical | 51862-295NDA |
| FLUOROURACIL | FLUOROURACIL | cream, topical | 51862-362ANDA |
| Halobetasol propionate | Halobetasol propionate | aerosol, foam, topical | 68308-769ANDA |
| IVERMECTIN | IVERMECTIN | cream, topical | 68308-701NDA AUTHORIZED GENERIC |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-570ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-571ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-573ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-575ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-781ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-782ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-783ANDA |
| Isotretinoin | Isotretinoin | capsule, liquid filled, oral | 68308-784ANDA |
| - | Itraconazole | capsule, gelatin coated | 50546-462DRUG FOR FURTHER PROCESSING |
| LEXETTE | halobetasol propionate | aerosol, foam, topical | 51862-618ANDA |
| Levora | levonorgestrel and ethinyl estradiol | kit | 51862-097ANDA |
| Low-Ogestrel | Norgestrel and Ethinyl Estradiol | kit | 51862-564ANDA |
| Lutera | levonorgestrel and ethinyl estradiol | kit | 51862-028ANDA |
| METRONIDAZOLE | METRONIDAZOLE | cream, topical | 68308-711NDA AUTHORIZED GENERIC |
| Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | capsule, extended release, oral | 51862-611ANDA |
| Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | capsule, extended release, oral | 51862-612ANDA |
| Metronidazole | metronidazole | gel, topical | 68308-663NDA AUTHORIZED GENERIC |
| Microgestin 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol | kit | 51862-872ANDA |
| Microgestin 1/20 | Norethindrone Acetate/Ethinyl Estradiol | kit | 51862-868ANDA |
| Microgestin 24 Fe | Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate | kit | 51862-648ANDA |
| Microgestin Fe 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | kit | 51862-870ANDA |
| Microgestin Fe 1/20 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | kit | 51862-866ANDA |
| Necon | norethindrone and ethinyl estradiol | kit, oral | 51862-892ANDA |
| Nextstellis | drospirenone and estetrol | kit | 51862-258NDA |
| Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | capsule, oral | 51862-016ANDA |
| Nymyo | norgestimate and ethinyl estradiol | kit | 51862-645ANDA |
| Rhofade | oxymetazoline hydrochloride | cream, topical | 51862-765NDA |
| Rhofade | oxymetazoline hydrochloride | cream, topical | 68308-766NDA |
| SOLTAMOX | TAMOXIFEN CITRATE | liquid, oral | 51862-682NDA |
| SORILUX | calcipotriene | aerosol, foam, topical | 51862-376NDA |
| SRONYX | Levonorgestrel and Ethinyl Estradiol | kit | 51862-545ANDA |
| Tazarotene | TAZAROTENE | cream, topical | 68308-745ANDA |
| Tilia Fe | NdAc and EE Tablets and Ferrous Fumarate Tablets | kit | 51862-896ANDA |
| Tretinoin (Microsphere) | tretinoin | gel, topical | 68308-777ANDA |
| Tri-Nymyo | Norgestimate and Ethinyl Estradiol | kit | 51862-646ANDA |
| Zovia 1/35 | Ethynodiol Diacetate and Ethinyl Estradiol Tablets | kit | 51862-894ANDA |
| adapalene and benzoyl peroxide | adapalene and benzoyl peroxide | gel, topical | 68308-662NDA AUTHORIZED GENERIC |
| calcipotriene | calcipotriene | aerosol, foam, topical | 51862-512NDA |
| clobetasol propionate | clobetasol propionate | shampoo, topical | 68308-664NDA AUTHORIZED GENERIC |
| - | doxycycline hyclate | tablet, delayed release | 50546-560DRUG FOR FURTHER PROCESSING |
| - | erythromycin | capsule, delayed release pellets | 50546-250DRUG FOR FURTHER PROCESSING |
| metronidazole | metronidazole | lotion, topical | 68308-712NDA AUTHORIZED GENERIC |
| tazarotene | tazarotene | aerosol, foam, topical | 68308-685NDA AUTHORIZED GENERIC |
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Enquiry
Common questions
- Is Mayne Pharma International Pty Ltd. FDA approved?
- Mayne Pharma International Pty Ltd. holds 1 FDA-registered establishment in Australia. 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 Mayne Pharma International Pty Ltd.'s drugs manufactured?
- The FDA register lists Salisbury South. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Mayne Pharma International Pty Ltd. make?
- 64 products are listed under Mayne Pharma International Pty Ltd. in the openFDA NDC Directory, most often as kit; capsule, liquid filled; aerosol, foam. 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.