Application 061147

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	TABLET;ORAL	250MG	No	No
002	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A061147-001	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	250MG	TABLET / ORAL	Approved before 1982
A061147-002	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982
A061147-003	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
A061147-004	SUMYCIN	TETRACYCLINE HYDROCHLORIDE	500MG	TABLET / ORAL	RS, Approved before 1982

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061147-001	SUMYCIN	250MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061147-002	SUMYCIN	100MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061147-003	SUMYCIN	50MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061147-004	SUMYCIN	500MG	TABLET / ORAL	RS, Approved before 1982	`d8e5a09893c0…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Pharmaka Generics Inc.	c522c860-84ce-4c61-ab72-077de73195df	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061147 application number: ANDA061147

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-732	SUMYCIN	Tetracycline Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-733	SUMYCIN	Tetracycline Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current