LEVONORGESTREL AND ETHINYL ESTRADIOL
- Product NDC
- 57994-008
- 11-digit product format
- 579940008
- Labeler code
- 57994
- Product ID
- 57994-008_b175b0fd-79f5-4001-b371-30e859522c5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Jai Pharma Limited
- Application
- ANDA200493
- Marketing category
- ANDA
- Marketing start
- 2017-01-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57994-008-90 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57994-008-90 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200493-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A200493-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | 0.02MG,0.1MG;0.01MG,N/A | TABLET / ORAL | AB | 2015-06-17 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200493-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200493-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200493-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200493-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200493-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200493-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200493-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200493-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200493-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200493-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200493-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200493-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200493-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200493-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200493-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200493-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200493-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200493-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A200493-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A200493-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A200493-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A200493-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200493-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A200493-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A200493-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A200493-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A200493-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A200493-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A200493-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200493-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A200493-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A200493-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200493-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200493-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200493-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200493-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A200493-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A200493-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200493-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A200493-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57994-008-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d7-f424-e053-dadaa90a57ce | Levonorgestrel and Ethinyl Estradiol Tablets USP, (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets USP, (0.01 mg) |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LOJAIMIESS | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS | Xiromed LLC | 2a20c571-59c7-cadf-dcf7-1b4707c661a3 | 2024-09-16 | Boxed warning, Warnings, Adverse reactions | 200493 ANDA200493 |
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | ada28708-ab65-4c07-a695-9141c5ce26bc | 2023-04-20 | Boxed warning, Warnings, Adverse reactions | 200493 ANDA200493 |